HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation

The Health Sciences Authority (HSA) is committed to ensuring the rapid availability of diagnostic tests for COVID-19 in Singapore. Since 29 January 2020, HSA has been closely providing regulatory and scientific advice to research institutions as well as local and multi-national companies to ensure the timely availability of good quality performing test kits that are critical during this period of need.

See Table below for more information on the diagnostic tests that we have approved to date via provisional authorisation.

Provisional authorisation

To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. This has helped expand the number and variety of diagnostic tests available in Singapore.

This provisional authorisation is based on a risk-calibrated review process that considers the design aspects of the test (e.g. primers and probe design, target sequence in the viral RNA) and the supporting validation data122 KB (e.g. Limit of detection, cross reactivity, inclusivity). Periodic reports on specific data on the safety and/or performance of these tests will be required to be submitted to HSA post authorisation to assure the continued performance of these devices. If any safety or performance issues are observed, HSA will require relevant follow up actions at the manufacturer’s end.

This provisional authorisation has been implemented as an interim measure in response to the current public health need for timely detection of COVID-19 infections.

Update:

From 1 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 test.

For tests that have been granted provisional authorisation, the authorisation will remain valid till 31 December 2021.

From 1 January 2022, all COVID-19 tests supplied in Singapore should be registered with HSA or received authorisation under the Pandemic Special Access Route (PSAR).

From 1 June 2021, HSA will stop accepting new provisional authorisation applications for COVID-19 tests. All new tests for supply in Singapore should be submitted for full-fledged registration. You can find more information on product registration here.

Where there are new tests that are not registered with HSA in 2021 and the Ministry of Health (MOH) determines that there is a clinical need for the use of these tests from or after 1 January 2022, MOH would consider designating these tests as “emergency medical devices”. Only such tests would qualify for the Pandemic Special Access Route (PSAR). HSA would evaluate to determine if these tests meet the appropriate standards of safety, quality and efficacy applicable to these tests and authorise these tests under the PSAR.

For all COVID-19 tests granted provisional authorisation, the provisional authorisation will remain valid till 31 December 2021.

From 1 January 2022, only diagnostic tests which have received full-fledged registration approval with HSA, or authorisation under the Pandemic Special Access Route (PSAR), shall be supplied in Singapore

If you have any questions regarding this provisional authorisation process, please contact us here.

The Table below lists the COVID-19 tests that have received provisional authorisation to date. It will be updated as more tests gets approved:

No.	Applicant	Name of test	For more information
PCR Based Molecular Tests
1	Veredus Laboratories Pte Ltd	VereCoV™ Detection Kit	Veredus Laboratories Pte Ltd444 KB
2	AITbiotech Pte Ltd	abTES™ COVID-19 qPCR I Kit	AITbiotech Pte Ltd446 KB
3	DSO National Laboratories	Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus	DSO National Laboratories442 KB
4	Roche Diagnostics Asia Pacific Pte Ltd	Cobas® SARS-CoV-2	Roche_cobas SARS-CoV-2_Provisional Authorisation for Covid-19 tests_1306021105 KB
5	JN Medsys Pte Ltd	ProTect™ COVID-19 RT-qPCR Kit	JN Medsys_Provisional Authorisation for Covid-19_17042020443 KB
6	Life Technologies Holdings Pte Ltd	TaqPath™ COVID-19 Combo Kit	Life Technologies_Provisional Authorisation for Covid-19 tests_12052020449 KB
7	Biowalker Pte Ltd	Novel Coronavirus (2019-nCoV) RNA kit (Isothermal Amplification- Real Time Fluorescence Assay)	Biowalker_Novel Coronavirus (2019-nCoV) RNA kit_Provisional Authorisation for Covid-19 tests_24102020102 KB
8	SPD Scientific Pte Ltd	Cepheid® Xpert® Xpress SARS-CoV-2	SPD_Cepheid® Xpert® Xpress SARS-CoV-2_Provisional Authorisation for Covid-19 tests_14102020100 KB
9	MiRXES Pte Ltd	MiRXES FORTITUDE KIT 2.0	MiRXES_Provisional Authorisation for Covid-19 tests_17042020439 KB
10	Acumen Research Laboratories	Acu-Corona™ 2.0	Acumen Research Laboratories Pte Ltd442 KB
11	Credo Diagnostics Biomedical Pte Ltd	VitaPCR™ SARS-CoV-2 Assay	Credo Diagnostics Biomedical Pte Ltd443 KB
12	Abbott Laboratories (Singapore) Pte Ltd	Abbott RealTime SARS-CoV-2 assay	Abbott Laboratories (Singapore) Pte Ltd445 KB
13	All Eights (Singapore) Pte Ltd	Seegene Allplex^TM 2019-nCoV Assay	All Eights (Singapore) Pte Ltd444 KB
14	Vela Operations Singapore Pte Ltd	ViroKey SARS-CoV-2 RT-PCR Test	Vela_Provisional Authorisation for Covid-19 tests_17042020441 KB
15	PerkinElmer Singapore Pte Ltd	PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay	PerkinElmer_Provisional Authorisation for Covid-19 tests_24042020438 KB
16	Medicell Pharmaceutical (S) Pte Ltd	Sansure Biotech Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit	Medicell_Provisional Authorisation for Covid-19 tests_24042020448 KB
17	BGI Health (SG) Company Pte Ltd	Real-time fluorescent RT-PCR kit for detecting 2019-nCoV	BGI_Provisional Authorisation for Covid-19 tests_12052020457 KB
18	Diagnostics Development Hub (DxD)	Fortitude™ Kit 2.1	DXD_Provisional Authorisation for Covid-19 tests_05052020444 KB
19	Genomax Technologies Pte Ltd	Allplex 2019-nCoV Assay	Genomax_Provisional Authorisation for Covid-19 tests_05052020446 KB
20	Tanglin Cardiology Pte Ltd	Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit	Tanglin_Provisional Authorisation for Covid-19 tests_05052020451 KB
21	Becton Dickinson Holding Ptd Ltd	BD SARS-CoV-2 Reagents for BD MAX™ System	Becton Dickinson_Provisional Authorisation for Covid-19 tests__06052020450 KB
22	Biomed Diagnostics Pte Ltd	Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit	Biomed_Provisional Authorisation for Covid-19 tests_06052020455 KB
23	Biomed Diagnostics Pte Ltd	Luminex NxTAG® CoV Extended Panel Assay	Biomed_Luminex_Provisional Authorisation for Covid-19 tests_12052020443 KB
24	MiRXES Pte Ltd	MiRXES Fortitude Kit 2.1	MiRXES_Fortitude 2.1_Provisional Authorisation for Covid-19 tests_12052020440 KB
25	BioMérieux Singapore Pte Ltd	BioFire® Respiratory Panel 2.1 (RP2.1)	BioMérieux_Provisional Authorisation for Covid-19 tests_15052020442 KB
26	SPD Scientific Pte Ltd	GeneFinder™ COVID-19 Plus RealAmp Kit	SPD_GeneFinder_Provisional Authorisation for Covid-19 tests_15052020449 KB
27	SDT Molecular Pte Ltd	altona Diagnostics RealStar™ SARS-CoV-2 RT-PCR Kit 1.0	SDT_Provisional Authorisation for Covid-19 tests_19052020445 KB
28	AMT Pte Ltd	AMT RESOLUTE 1.0	AMT_Provisional Authorisation for Covid-19 tests_22052020433 KB
29	Siemens Healthcare Pte Ltd	FTD™ SARS-CoV-2	Siemens_FTD_Provisional Authorisation for Covid-19 tests_28052020131 KB
30	Qiagen Singapore Pte. Ltd	QIAstat-Dx® Respiratory SARS-CoV-2 Panel	Qiagen_QIAstat_Provisional Authorisation for Covid-19 tests_02062020137 KB
31	Veredus Laboratories Pte Ltd	VereRT™ COVID-19 PCR Kit	Veredus_VereRT™_Provisional Authorisation for Covid-19 tests_23092020101 KB
32	XIN Pte Ltd	Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit	Xin_Fosun_Provisional Authorisation for Covid-19 tests_19062020130 KB
33	Credo Diagnostics Biomedical Pte Ltd	VitaPCR™ SARS-CoV-2 Gen 2 Assay	Credo_VitaPCR_Provisional Authorisation for Covid-19 tests_19062020132 KB
34	Biomed Diagnostics Pte Ltd	Luminex ARIES® SARS-CoV-2 Assay	Biomed_Luminex Aries_Provisional Authorisation for Covid-19 tests_19062020132 KB
35	All Eights (Singapore) Pte Ltd	Hologic Aptima® SARS-CoV-2 assay	All Eights_Hologic_Provisional Authorisation for Covid-19 tests_21022021107 KB
36	Accelerate Technologies Pte Ltd (DxD Hub)	Accelerate Technologies Resolute 2.0 assay	Accelerate Technologies_Resolute 2.0_Provisional Authorisation for Covid-19 tests_21022021104 KB
37	Andaman Medical Pte Ltd	Seegene Allplex™ SARS-CoV-2 Assay	Andaman_Seegene_Provisional Authorisation for Covid-19 tests_25062020128 KB
38	EMERGO by UL	AccuraDTect SARS-CoV-2 RT-qPCR Kit	Emergo_AccuraDTect_Provisional Authorisation for Covid-19 tests_03072020128 KB
39	Vela Operations Singapore Pte Ltd	ViroKey™ SARS-CoV-2 RT-PCR Test v2.0	Vela_ViroKey_Provisional Authorisation for Covid-19 tests_03072020130 KB
40	Biotrilance Pte Ltd	Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	Biotrilance_Novel_Provisional Authorisation for Covid-19 tests_09072020134 KB
41	JN Medsys Pte Ltd	ProTect COVID-19 RT-qPCR Kit 2.0	JN Medsys_ProTect_Provisional Authorisation for Covid-19 tests_09072020129 KB
42	Alliance BioMed Pte Ltd	Alliance Resolute 2.0	Alliance BioMed_Resolute 2.0_Provisional Authorisation for Covid-19 tests_03072021104 KB
43	Life Technologies Holdings Pte Ltd	TaqPath™ COVID 19 CE IVD RT PCR Kit	Life Technologies_TaqPath_Provisional Authorisation for Covid-19 tests_28072020136 KB
44	BioMérieux Singapore Pte Ltd	BioFire® Respiratory Panel 2.1 plus (RP2.1plus)	BioMérieux_BioFire_Provisional Authorisation for Covid-19 tests_28072020131 KB
45	All Eights (Singapore) Pte Ltd	StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit	All Eights_StrongStep_Provisional Authorisation for Covid-19 tests_28072020132 KB
46	Gaia Science Pte Ltd	genesig® Real-Time PCR COVID-19 (Swab Use)	Gaia_genesig_Provisional Authorisation for Covid-19 tests_18082020131 KB
47	Veredus Laboratories Pte Ltd	VereRT™ ZeroPrep™ COVID-19 PCR Kit	Veredus_VereRT™ ZeroPrep™_Provisional Authorisation for Covid-19 tests_07122020103 KB
48	Link Trust Laboratories Pte Ltd	DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection kit	Linktrust_DiaPlexQ_Provisional Authorisation for Covid-19 tests_18082020137 KB
49	Illumina Singapore Pte Ltd	Illumina COVIDSeq Test	Illumina_COVIDSeq Test_Provisional Authorisation for Covid-19 tests_25122020102 KB
50	INEX Innovate Pte Ltd	CORO Real-Time RT-PCR SARSCoV-2	INEX_CORO Real-Time RT-PCR_Provisional Authorisation for Covid-19 tests_25122020101 KB
51	BioAcumen Global Pte Ltd	BioA SARS-CoV-2 Real-Time RT-PCR Kit v1.0	BioAcumen_BioA_Provisional Authorisation for Covid-19 tests_17092020103 KB
52	Cellbae Pte Ltd	TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit	Cellbae_TEPAT_Provisional Authorisation for Covid-19 tests_17092020102 KB
53	Abbott Laboratories (S) Pte Ltd	Abbott Alinity m SARS-CoV-2 AMP Kit	Abbott_Alinity m_Provisional Authorisation for Covid-19 tests_17092020103 KB
54	QuikPath Pte Ltd	QuikPath SARS-CoV-2 Isothermal RT- PCR Kit	QuikPath_SARS-CoV-2 Isothermal _Provisional Authorisation for Covid-19 tests_17092020101 KB
55	Biorodi Company Pte Ltd	Xiamen Zeesan SARS-CoV-2 Test Kit (Real-time PCR)	Biorodi_Xiamen Zeesan_Provisional Authorisation for Covid-19 tests_02102020101 KB
56	Veredus Laboratories Pte Ltd	VereCoV™ OneMix Detection Kit	Veredus_VereCoV™ OneMix_Provisional Authorisation for Covid-19 tests_14102020101 KB
57	Biomed Diagnostics Pte Ltd	InnoCare SARS-CoV-2 RT-PCR Kit	Biomed_InnoCare SARS-CoV-2 RT-PCR Kit_Provisional Authorisation for Covid-19 tests_13032021102 KB
58	MiRXES Pte Ltd	MiRXES Fortitude SARS-CoV-2 & FluA/B Test	MiRXES_Fortitude SARS-CoV-2 and Flu A B Test_Provisional Authorisation for Covid-19 tests_10012021103 KB
59	IceSing Bioscience Pte Ltd	DirectDetect SARS-CoV-2 Detection Kit	IceSing Bioscience_DirectDetect_Provisional Authorisation for Covid-19 tests_15012021101 KB
60	Shimadzu (Asia Pacific) Pte Ltd	Shimadzu Ampdirect 2019-nCoV Detection Kit	Shimadzu_Ampdirect_Provisional Authorisation for Covid-19 tests_15012021105 KB
61	SPD Scientific Pte Ltd	Cepheid® Xpert® Xpress SARS-CoV-2/Flu/RSV Assay	SPD_Cepheid Xpert_Provisional Authorisation for Covid-19 tests_15012021102 KB
62	MiRXES Pte Ltd	MiRXES Fortitude Kit 3.0	MiRXES_Fortitude Kit 3.0_Provisional Authorisation for Covid-19 tests_07022021101 KB
63	Roche Diagnostics Asia Pacific Pte Ltd	cobas® Liat SARS-CoV-2 & Influenza A/B	Roche_cobas Liat SARS-CoV-2 & Influenza A B_Provisional Authorisation for Covid-19 tests_11022021105 KB
64	Acumen Research Laboratories Pte Ltd	Acu-Corona Duplex	Acumen_Acu-Corona Duplex_Provisional Authorisation for Covid-19 tests_2803202198 KB
65	Acumen Research Laboratories Pte Ltd	Satugen Duplex	Acumen_Satugen Duplex_Provisional Authorisation for Covid-19 tests_2803202198 KB
66	Cellbae Pte Ltd	TEPAT 2.0 SARS-CoV-2 Multiplex Direct RT-PCR Kit	Cellbae_TEPAT 2.0_Provisional Authorisation for Covid-19 tests_17092021102 KB
Antigen Tests (For use by Professionals; Not for consumer use)
1	Xentific Labs Pte Ltd	Standard Q COVID-19 Ag Test	Xentific_Standard Q_Provisional Authorisation for Covid-19 tests_08062020135 KB
2	Alcotech Pte Ltd	FaStep COVID-19 Antigen Rapid Test Device (Nasopharyngeal/ Oropharyngeal Swab)	Alcotech_FaStep_Provisional Authorisation for Covid-19 tests_09072020132 KB
3	Hi-Beau Group	SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)	Hi-Beau Group_SAVANT_Provisional Authorisation for Covid-19 tests_17072020138 KB
4	Becton Dickinson Holding Ptd.Ltd	BD Veritor™ System for Rapid Detection of SARS-CoV-2	BD_Veritor_Provisional Authorisation for Covid-19 tests_13062021109 KB
5	SPD Scientific Pte Ltd	Standard Q COVID-19 Ag Test	SPD Scientific_Standard Q_Provisional Authorisation for Covid-19 tests_28072020135 KB
6	Quantum Technologies Global Pte Ltd	Sofia SARS Antigen FIA	Quantum_Sofia_Provisional Authorisation for Covid-19 tests_06082020134 KB
7	Jian Yuan Holdings Pte Ltd	COVID-19 Antigen Rapid Test Kit	Jian Yuan_COVID-19 Antigen_Provisional Authorisation for Covid-19 tests_01092020102 KB
8	Camtech Diagnostics Pte Ltd	Camtech COVID-19 Antigen Rapid Test	Camtech_COVID-19 Antigen_Provisional Authorisation for Covid-19 tests_01092020102 KB
9	Unison Collaborative Pte Ltd	GenBody COVID-19 Ag	Unison_GenBody COVID-19 Ag_Provisional Authorisation for Covid-19 tests_08092020102 KB
10	Tigermed Asia Pacific Private Limited	GenBody COVID-19 Ag	Tigermed_GenBody_Provisional Authorisation for Covid-19 tests_23092020102 KB
11	All Eights (Singapore) Pte Ltd	ESPLINE® SARS-CoV-2	All Eights_ESPLINE®_Provisional Authorisation for Covid-19 tests_02102020101 KB
12	Unison Collaborative Pte Ltd	Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)	Unison_Panbio_Provisional Authorisation for Covid-19 tests_18102020104 KB
13	Biomed Diagnostics Pte Ltd	BIOCREDIT COVID-19 Ag	Biomed_BIOCREDIT_Provisional Authorisation for Covid-19 tests_18102020102 KB
14	Roche Diagnostics Asia Pacific Pte Ltd	SARS-CoV-2 Rapid Antigen Test	Roche_SARS-CoV-2 Rapid Antigen Test_Provisional Authorisation for Covid-19 tests_31012021100 KB
15	Everest Links Pte Ltd	VivaDiag™ SARS-CoV-2 Ag Rapid Test	Everest_VivaDiag_Provisional Authorisation for Covid-19 tests_31102020102 KB
16	Veredus Laboratories Pte Ltd	SGTi-flex COVID-19 Ag	Veredus_SGTi-flex_Provisional Authorisation for Covid-19 tests_31102020101 KB
17	Zyfas Pharma Pte Ltd	SGTi-flex COVID-19 Ag	Zyfas_SGTi-flex COVID-19 Ag_Provisional Authorisation for Covid-19 tests_15112020103 KB
18	Amaquest Pte Ltd	GenBody COVID-19 Ag	Amaquest_GenBody COVID-19 Ag_Provisional Authorisation for Covid-19 tests_15112020101 KB
19	Andaman Medical Pte Ltd	GENEDIA W COVID-19 Ag	Andaman_GENEDIA W COVID-19 Ag_Provisional Authorisation for Covid-19 tests_21112020102 KB
20	Biolidics Limited	SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)	Biolidics_SARS-CoV-2 Antigen Rapid Test Kit_Provisional Authorisation for Covid-19 tests_01122020104 KB
21	Unison Collaborative Pte Ltd	Panbio™ COVID-19 Ag Rapid Test Device (Nasal)	Unison_Panbio™ COVID-19 Ag Rapid Test Device_Provisional Authorisation for Covid-19 tests_01122020104 KB
22	Amaquest Pte Ltd	SGTi-flex COVID-19 Ag	Amaquest_SGTi-flex COVID-19 Ag_Provisional Authorisation for Covid-19 tests_07122020102 KB
23	Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack	Ortho Clinical_VITROS Antigen Reagent Pack_Provisional Authorisation for Covid-19 tests_07122020104 KB
24	SG Diagnostics Pte Ltd	COVID-19 Antigen Test	SG Diagnostics_COVID-19 Antigen Test_Provisional Authorisation for Covid-19 tests_07122020105 KB
25	Deel Pte Ltd	Dynamiker SARS-CoV-2 Ag Rapid Test	Deel_Dynamiker SARS-CoV-2 Ag_Provisional Authorisation for Covid-19 tests_13122020103 KB
26	HealthGroup Medical Pte Ltd	V-CODE ENCODE SARS-COV-2 Antigen Rapid Test Device	HealthGroup_V-CODE ENCODE SARS-COV-2_Provisional Authorisation for Covid-19 tests_13122020104 KB
27	Hermes-Epitek Corporation Pte Ltd	Vstrip COVID-19 Antigen Rapid Test	Hermes-Epitek_Vstrip_Provisional Authorisation for Covid-19 tests_25122020104 KB
28	SG Diagnostics Pte Ltd	SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)	SG Diagnostics_COVID-19 Antigen Rapid Test Kit_Provisional Authorisation for Covid-19 tests_10012021106 KB
29	BioMedix Singapore Pte Ltd	CerTest SARS-CoV-2	BioMedix_CerTest SARS-CoV-2_Provisional Authorisation for Covid-19 tests_10012021102 KB
30	Xentific Labs Pte Ltd	CLUNGENE® COVID-19 Antigen Rapid Test Cassette	Xentific Labs_CLUNGENE_Provisional Authorisation for Covid-19 tests_10012021105 KB
31	SPD Scientific Pte Ltd	Dynamiker SARS-CoV-2 Ag Rapid Test	SPD_Dynamiker_Provisional Authorisation for Covid-19 tests_15012021103 KB
32	Sailfish Innovations Pte Ltd	Novel Coronavirus 2019 n-CoV Antigen Test (Colloidal Gold)	Sailfish_Novel Coronavirus Antigen Test (Colloidal Gold)_Provisional Authorisation for Covid-19 tests_31012021102 KB
33	SkyQuest Pte Ltd	Hangzhou Alltest COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)	SkyQuest_Hangzhou Alltest_Provisional Authorisation for Covid-19 tests_28022021105 KB
34	SK BIOTECH PTE LTD	Liming Bio StrongStep® System Device for SARS-CoV-2 Antigen Rapid Test	SK BIOTECH_Liming Bio StrongStep_Provisional Authorisation for Covid-19 tests_28022021103 KB
35	ARISTA Biotech Pte Ltd	ARISTA™ COVID-19 Antigen Rapid Test	ARISTA_COVID-19 Antigen Rapid Test_Provisional Authorisation for Covid-19 tests_07032021102 KB
36	Siemens Healthcare Pte Ltd	Siemens ADVIA Centaur® SARS-CoV-2 Antigen (CoV2Ag)	Siemens_ADVIA Centaur® SARS-CoV-2 Antigen (CoV2Ag)_Provisional Authorisation for Covid-19 tests_09052021104 KB
37	Siemens Healthcare Pte Ltd	Siemens Atellica® IM SARS-CoV-2 Antigen (CoV2Ag)	Siemens_Atellica® IM SARS-CoV-2 Antigen (CoV2Ag)_Provisional Authorisation for Covid-19 tests_09052021104 KB
38	SPD Scientific Pte Ltd	Standard Q COVID-19 Ag Test (Nasal Swab)	SPD_Standard Q COVID-19 Ag Test (Nasal Swab)_Provisional Authorisation for Covid-19 tests_03042021104 KB
39	Roche Diagnostics Asia Pacific Pte Ltd	Roche Elecsys SARS-CoV-2 Antigen	Roche_Elecsys SARS-CoV-2 Antigen_Provisional Authorisation for Covid-19 tests_03042021103 KB
40	Siemens Healthcare Pte Ltd	CLINITEST Rapid COVID-19 Antigen Test	Siemens_CLINITEST_Provisional Authorisation for Covid-19 tests_23052021105 KB
41	Roche Diagnostics Asia Pacific Pte Ltd	SARS-CoV-2 Rapid Antigen Test Nasal	Roche_SARS-CoV-2 Rapid Antigen Test Nasal_Provisional Authorisation for Covid-19 tests_04062021105 KB
42	Delphi Bioscience Asia Pte Ltd	Lumigenex PocRoc SARS-CoV-2 Antigen Rapid Test Kit (TRFIA)	Delphi Bioscience_Lumigenex PocRoc_Provisional Authorisation for Covid-19 tests_31072021105 KB
Antibody (Serology) Tests
1	Everest Links Pte Ltd	VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test	Everest Links_Provisional Authorisation for Covid-19 tests_03072020130 KB
2	Biolidics Limited	Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit also marketed as Biolidics 2019-nCoV IgG/IgM Detection Kit	Biolidics Limited451 KB
3	SkyQuest Pte Ltd	Wondfo 2019-nCoV Antibody Test (Lateral Flow Method)	SkyQuest_Wondfo Antibody Test (Lateral Flow Method)_Provisional Authorisation for Covid-19 tests_11022021103 KB
4	Camtech Diagnostics Pte Ltd	Camtech COVID-19 IgM/IgG	Camtech Diagnostics Pte Ltd442 KB
5	Grit Overseas Pte Ltd	DiagnoSure COVID-19 IgG/ IgM Rapid Test Cassette	Grit_Provisional Authorisation for Covid-19 tests_24042020445 KB
6	Veredus Laboratories Pte Ltd	Shanghai LiangRun LionRun Diagnostic Kit for Antibody IgM-IgG of Novel Coronavirus COVID-19	Veredus_Provisional Authorisation for Covid-19 tests_05052020454 KB
7	Bioforge Solutions Pte Ltd	INNOVITA 2019-nCoV Ab Test (Colloidal Gold)	Bioforge_INNOVITA_Provisional Authorisation for Covid-19 tests_05052020451 KB
8	Bioforge Solutions Pte Ltd	Wondfo 2019-nCoV Antibody Test (Lateral Flow Method)	Bioforge_Wondfo_Provisional Authorisation for Covid-19 tests_28022021104 KB
9	Abbott Laboratories (S) Pte Ltd	Abbott SARS-CoV-2 IgG – ARCHITECT assay	Abbott_Provisional Authorisation for Covid-19 tests_05052020444 KB
10	Roche Diagnostics Asia Pacific Pte Ltd	Roche Elecsys Anti-SARS-CoV-2	Roche_Provisional Authorisation for Covid-19 tests_05052020443 KB
11	Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack	Ortho Clinical Diagnostics_Provisional Authorisation for Covid-19 tests_15052020455 KB
12	MP Biomedicals Asia Pacific Pte Ltd	MP Diagnostics ASSURE® SARS-CoV-2 IgG/IgM Rapid Test	MP Biomedicals_Provisional Authorisation for Covid-19 tests_09072020134 KB
13	Biomed Diagnostics Pte Ltd	INNOVITA 2019-nCoV Ab Test (Colloidal Gold)	Biomed_Innovita_Provisional Authorisation for Covid-19 tests_12052020450 KB
14	Genscript Biotech (Singapore) Pte Ltd	cPass^TM SARS-CoV-2 Neutralization Antibody Detection Kit	Genscript_cPass_Provisional Authorisation for Covid-19 tests_18082020132 KB
15	Trans Sahara Corporation Pte Ltd	Xiamen Boson Rapid 2019-nCOV IgG/IgM Combo Test Card	Trans Sahara_Provisional Authorisation for Covid-19 tests_15052020448 KB
16	All Eights (Singapore) Pte Ltd	EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit	All Eights_EDI IgG_Provisional Authorisation for Covid-19 tests_19052020446 KB
17	All Eights (Singapore) Pte Ltd	EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit	All Eights_EDI IgM_Provisional Authorisation for Covid-19 tests_19052020445 KB
18	Healthgroup Medical Pte Ltd	HealthGroup Medical V-CODE Sars-CoV-2 (COVID-19) IgG/IgM Rapid Test	Healthgroup_Provisional Authorisation for Covid-19 tests_19052020446 KB
19	I-Test Pte Ltd	i-Test COVID -19 IgM/IgG Antibody Rapid Test (Colloidal Gold)	I-Test_Provisional Authorisation for Covid-19 tests_22052020442 KB
20	Ying Assets Management Pte Ltd	INNOVITA 2019-nCoV Ab Test (Colloidal Gold)	Ying Assets_Provisional Authorisation for Covid-19 tests_22052020443 KB
21	Abbott Laboratories (S) Pte Ltd	ABBOTT Alinity i SARS-CoV-2 IgG	Abbott_Alinity_Provisional Authorisation for Covid-19 tests_28052020127 KB
22	COBS Pte Ltd	BIOSYNEX COVID-19 BSS	COBS_BIOSYNEX_Provisional Authorisation for Covid-19 tests_28052020127 KB
23	Euroimmun (South East Asia) Pte Ltd	EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG)	EUROIMMUN_Anti-SARS-CoV-2 ELISA (IgG)_Provisional Authorisation for Covid-19 tests_21022021104 KB
24	SPD Scientific Pte Ltd	2019-nCoV IgG/IgM Rapid Test	SPD Scientific_2019-nCoV_Provisional Authorisation for Covid-19 tests_02062020133 KB
25	Trident Pharm Pte Ltd	SARS-CoV-2 Antibody Test Strip	Trident_SARS-CoV-2_Provisional Authorisation for Covid-19 tests_02062020124 KB
26	Sinch Medical Pte Ltd	2019-nCOV/COVID-19 IgG/IgM Rapid Test Device	Sinch_2019-nCov_Provisional Authorisation for Covid-19 tests_02062020133 KB
27	Euroimmun (South East Asia) Pte. Ltd.	EUROIMMUN Anti-SARS-CoV-2 ELISA (IgA)	EUROIMMUN_Anti-SARS-CoV-2 ELISA (IgA)_Provisional Authorisation for Covid-19 tests_21022021103 KB
28	Transmedic Pte Ltd	Genrui Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)	Transmedic_Genrui_Provisional Authorisation for Covid-19 tests_12062020132 KB
29	Siemens Healthcare Pte Ltd	Siemens Atellica® IM SARS-CoV-2 Total (COV2T)	Siemens_Atellica_Provisional Authorisation for Covid-19 tests_02062020129 KB
30	Siemens Healthcare Pte Ltd	Siemens ADVIA Centaur® SARS-CoV-2 Total (COV2T)	Siemens_ADVIA_Provisional Authorisation for Covid-19 tests_02062020129 KB
31	Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack	Ortho Clinical_VITROS_Provisional Authorisation for Covid-19 tests_08062020143 KB
32	Alcotech Pte Ltd	Hangzhou AllTest 2019-nCoV IgG/IgM Rapid Test Cassette	Alcotech_Hangzhou AllTest_Provisional Authorisation for Covid-19 tests_17092021102 KB
33	Unison Collaborative Pte Ltd	RightSign COVID-19 IgG/IgM Rapid Test Cassette	Unison_RightSign_Provisional Authorisation for Covid-19 tests_12062020131 KB
34	Bio-Rad Laboratories (Singapore) Pte Ltd	Biorad Platelia SARS-CoV-2 Total Ab	Biorad_Platelia_Provisional Authorisation for Covid-19 tests_25062020128 KB
35	Beckman Coulter Singapore Pte Ltd	ACCESS SARS-CoV-2 IgG	Beckman Coulter_Access_Provisional Authorisation for Covid-19 tests_03072020128 KB
36	Unison Collaborative Pte Ltd	Panbio™ COVID-19 IgG/IgM Rapid Test Device	Unison_Panbio_Provisional Authorisation for Covid-19 tests_25062020137 KB
37	RAS Pharma and Biochem Pte Ltd	RAS Rapid Test - 2019-nCov IgG/IgM Rapid Test	RAS Pharma_RAS Rapid_Provisional Authorisation for Covid-19 tests_25062020133 KB
38	Cell ID Pte Ltd	Smart COVID-19 IgM-IgG Rapid Diagnostic Test	Cell ID_Smart_Provisional Authorisation for Covid-19 tests_03072020132 KB
39	Restalyst Pte Ltd	RAPIT COVID-19 IgM/IgG Test Kit	Restalyst_Rapit_Provisional Authorisation for Covid-19 tests_03072020131 KB
40	Genomax Technologies Pte Ltd	Hangzhou Lysun 2019-nCoV IgG/IgM Rapid Test Device	Genomax_Hangzhou Lysun_Provisional Authorisation for Covid-19 tests_09072020133 KB
41	Siemens Healthcare Pte Ltd	Siemens Atellica® IM SARS-CoV-2 IgG (COV2G)	Siemens_Atellica_Provisional Authorisation for Covid-19 tests_17072020132 KB
42	Siemens Healthcare Pte Ltd	Siemens ADVIA Centaur® SARS-CoV-2 IgG (COV2G)	Siemens_ADVIA Centaur_Provisional Authorisation for Covid-19 tests_17072020132 KB
43	EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.	EUROIMMUN Anti-SARS-CoV-2 NCP ELISA (IgG)	EUROIMMUN_NCP_Provisional Authorisation for Covid-19 tests_06082020133 KB
44	Restalyst Pte Ltd	Restalyst COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA	Restalyst_COVID19N_Provisional Authorisation for Covid-19 tests_18082020139 KB
45	Nova Diagnostics Pte Ltd	MAGLUMI 2019-nCoV IgG (CLIA)	Nova Diagnostics_MAGLUMI IgG_Provisional Authorisation for Covid-19 tests_2108202099 KB
46	Nova Diagnostics Pte Ltd	MAGLUMI 2019-nCoV IgM (CLIA)	Nova Diagnostics_MAGLUMI IgM_Provisional Authorisation for Covid-19 tests_2108202099 KB
47	Alcotech Pte Ltd	FaStep COVID-19 IgG/IgM Rapid Test Device	Alcotech_FaStep_Provisional Authorisation for Covid-19 tests_01092020103 KB
48	Abbott Laboratories (S) Pte Ltd	Abbott ARCHITECT SARS-CoV-2 IgM	Abbott_ARCHITECT SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_08092020101 KB
49	Abbott Laboratories (S) Pte Ltd	ABBOTT Alinity i SARS-CoV-2 IgM	Abbott_Alinity i SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_08092020101 KB
50	bioMérieux Singapore Pte Ltd	VIDAS® SARS-COV-2 IgG	bioMérieux_VIDAS® IgG_Provisional Authorisation for Covid-19 tests_14102020103 KB
51	bioMérieux Singapore Pte Ltd	VIDAS® SARS-COV-2 IgM	bioMérieux_VIDAS® IgM_Provisional Authorisation for Covid-19 tests_14102020103 KB
52	All Eights (Singapore) Pte Ltd	Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture)	All Eights_Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture)_Provisional Authorisation for Covid-19 tests_14102020141 KB
53	All Eights (Singapore) Pte Ltd	Ansh Labs SARS-CoV2 IgG ELISA	All Eights_Ansh Labs SARS-CoV2 IgG ELISA_Provisional Authorisation for Covid-19 tests_14102020101 KB
54	Roche Diagnostics Asia Pacific Pte Ltd	Roche Elecsys Anti-SARS-CoV-2 S	Roche_Elecsys Anti-SARS-CoV-2 S_Provisional Authorisation for Covid-19 tests_14102020102 KB
55	ZMC Technologies Pte Ltd	ichroma™ COVID-19 Ab	ZMC_ichroma™ COVID-19 Ab_Provisional Authorisation for Covid-19 tests_21112020100 KB
56	Biomed Diagnostics Pte Ltd	SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay)	Biomed_SARS-CoV-2 IgG_Provisional Authorisation for Covid-19 tests_07122020100 KB
57	Biomed Diagnostics Pte Ltd	SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay)	Biomed_SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_07122020100 KB
58	Beckman Coulter Singapore Pte Ltd	ACCESS SARS-CoV-2 IgM	Beckman Coulter_ACCESS SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_13122020107 KB
59	Nova Diagnostics Pte Ltd	MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA)	Nova Diagnostics_MAGLUMI (CLIA)_Provisional Authorisation for Covid-19 tests_07022021103 KB
60	Siemens Healthcare Pte Ltd	Siemens Atellica® IM SARS-CoV-2 IgG (sCOVG)	Siemens_Atellica IM SARS-CoV-2 IgG (sCOVG)_Provisional Authorisation for Covid-19 tests_07022021104 KB
61	Siemens Healthcare Pte Ltd	Siemens ADVIA Centaur® SARS-CoV-2 IgG (sCOVG)	Siemens_ADVIA Centaur SARS-CoV-2 IgG (sCOVG)_Provisional Authorisation for Covid-19 tests_07022021104 KB
62	Abbott Laboratories (S) Pte Ltd	Abbott ARCHITECT SARS-CoV-2 IgG II Quant	Abbott_ARCHITECT SARS-CoV-2 IgG II Quant_Provisional Authorisation for Covid-19 tests_04062021106 KB
63	Abbott Laboratories (S) Pte Ltd	Abbott Alinity i SARS-CoV-2 IgG II Quant	Abbott_Alinity i SARS-CoV-2 IgG II Quant_Provisional Authorisation for Covid-19 tests_04062021105 KB
64	Restalyst Pte Ltd	COVID19-REAAD™ Anti-SARS-CoV-2 IgG ELISA	Restalyst_COVID19-REAAD™ Anti-SARS-CoV-2 IgG ELISA_Provisional Authorisation for Covid-19 tests_03072021107 KB
Other tests
1	Breathonix Pte Ltd	BreFence Go COVID-19 Breath Test System	Breathonix_BreFence Go COVID-19 Breath Test System_Provisional Authorisation for Covid-19 tests_19052021106 KB
2	Silver Factory Technology Pte Ltd	TracieX Breathalyzer	Silver Factory_TracieX Breathalyzer_Provisional Authorisation for Covid-19 tests_28052021103 KB

Consumer, Healthcare professional, Industry member, Medical devices

Regulatory Updates