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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

2

AITbiotech Pte Ltd

 

abTES™ COVID-19 qPCR I Kit

3

DSO National Laboratories

Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus

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

6

Life Technologies Holdings Pte Ltd

TaqPath™ COVID-19 Combo Kit

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 AllplexTM 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
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

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
cPassTM 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
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