No. |
|
|
|
PCR Based Molecular Tests |
1 |
Diagnostics Development Hub (DxD)
|
|
|
2 |
Veredus Laboratories Pte Ltd
|
|
|
3 |
|
abTES™ COVID-19 qPCR I Kit
|
|
4 |
DSO National Laboratories
|
Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus
|
|
5 |
Roche Diagnostics Asia Pacific Pte Ltd
|
|
Roche_cobas SARS-CoV-2_Provisional Authorisation for Covid-19 tests_25122020104 KB
|
6 |
|
ProTect™ COVID-19 RT-qPCR Kit
|
|
7 |
Life Technologies Holdings Pte Ltd
|
TaqPath™ COVID-19 Combo Kit
|
|
8 |
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 |
9 |
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
|
10 |
MiRXES Pte Ltd |
MiRXES FORTITUDE KIT 2.0
|
MiRXES_Provisional Authorisation for Covid-19 tests_17042020439 KB
|
11 |
Acumen Research Laboratories
|
Acu-Corona™ 2.0 |
Acumen Research Laboratories Pte Ltd442 KB
|
12 |
Credo Diagnostics Biomedical Pte Ltd
|
VitaPCR™ SARS-CoV-2 Assay
|
Credo Diagnostics Biomedical Pte Ltd443 KB
|
13 |
Abbott Laboratories (Singapore) Pte Ltd
|
Abbott RealTime SARS-CoV-2 assay
|
Abbott Laboratories (Singapore) Pte Ltd445 KB
|
14 |
All Eights (Singapore) Pte Ltd
|
Seegene AllplexTM 2019-nCoV Assay
|
All Eights (Singapore) Pte Ltd444 KB
|
15 |
Acumen Research Laboratories Pte Ltd
|
Acu-Corona 3.0
|
Acumen Research Laboratories Pte Ltd - Acu-Corona 3.0444 KB
|
16 |
Vela Operations Singapore Pte Ltd
|
ViroKey SARS-CoV-2 RT-PCR Test |
Vela_Provisional Authorisation for Covid-19 tests_17042020441 KB
|
17 |
PerkinElmer Singapore Pte Ltd |
PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
|
PerkinElmer_Provisional Authorisation for Covid-19 tests_24042020438 KB
|
18 |
BioWalker Pte Ltd
|
BioWalker SARS-CoV-2 Assay
|
Biowalker_Provisional Authorisation for Covid-19 tests_24042020438 KB
|
19 |
Medicell Pharmaceutical (S) Pte Ltd
|
Sansure Biotech Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit
|
Medicell_Provisional Authorisation for Covid-19 tests_24042020448 KB
|
20 |
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
|
21 |
Diagnostics Development Hub (DxD)
|
Fortitude™ Kit 2.1
|
DXD_Provisional Authorisation for Covid-19 tests_05052020444 KB
|
22 |
Genomax Technologies Pte Ltd
|
Allplex 2019-nCoV Assay
|
Genomax_Provisional Authorisation for Covid-19 tests_05052020446 KB
|
23 |
BioWalker Pte Ltd
|
BioWalker SARS-CoV-2 Assay 2.0
|
Biowalker_Provisional Authorisation for Covid-19 tests_05052020441 KB
|
24 |
Tanglin Cardiology Pte Ltd
|
Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit
|
Tanglin_Provisional Authorisation for Covid-19 tests_05052020451 KB
|
25 |
Becton Dickinson Holding Ptd Ltd
|
BD SARS-CoV-2 Reagents for BD MAX™ System
|
Becton Dickinson_Provisional Authorisation for Covid-19 tests__06052020450 KB
|
26 |
Biomed Diagnostics Pte Ltd
|
Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit |
Biomed_Provisional Authorisation for Covid-19 tests_06052020455 KB
|
27 |
Biomed Diagnostics Pte Ltd
|
Luminex NxTAG® CoV Extended Panel Assay
|
Biomed_Luminex_Provisional Authorisation for Covid-19 tests_12052020443 KB
|
28 |
MiRXES Pte Ltd
|
MiRXES Fortitude Kit 2.1
|
MiRXES_Fortitude 2.1_Provisional Authorisation for Covid-19 tests_12052020440 KB
|
29 |
BioMérieux Singapore Pte Ltd
|
BioFire® Respiratory Panel 2.1 (RP2.1)
|
BioMérieux_Provisional Authorisation for Covid-19 tests_15052020442 KB
|
30 |
SPD Scientific Pte Ltd
|
GeneFinder™ COVID-19 Plus RealAmp Kit
|
SPD_GeneFinder_Provisional Authorisation for Covid-19 tests_15052020449 KB
|
31 |
SDT Molecular Pte Ltd
|
altona Diagnostics RealStar™ SARS-CoV-2 RT-PCR Kit 1.0
|
SDT_Provisional Authorisation for Covid-19 tests_19052020445 KB
|
32 |
AMT Pte Ltd
|
AMT RESOLUTE 1.0
|
AMT_Provisional Authorisation for Covid-19 tests_22052020433 KB
|
33 |
Novena Global Healthcare Pte Ltd
|
Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
|
Novena_Fosun_Provisional Authorisation for Covid-19 tests_28052020131 KB
|
34 |
Siemens Healthcare Pte Ltd
|
FTD™ SARS-CoV-2
|
Siemens_FTD_Provisional Authorisation for Covid-19 tests_28052020131 KB
|
35 |
Qiagen Singapore Pte. Ltd
|
QIAstat-Dx® Respiratory SARS-CoV-2 Panel
|
Qiagen_QIAstat_Provisional Authorisation for Covid-19 tests_02062020137 KB
|
36 |
Veredus Laboratories Pte Ltd
|
VereRT™ COVID-19 PCR Kit
|
Veredus_VereRT™_Provisional Authorisation for Covid-19 tests_23092020101 KB
|
37 |
XIN Pte Ltd
|
Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
|
Xin_Fosun_Provisional Authorisation for Covid-19 tests_19062020130 KB
|
38 |
Credo Diagnostics Biomedical Pte Ltd
|
VitaPCR™ SARS-CoV-2 Gen 2 Assay |
Credo_VitaPCR_Provisional Authorisation for Covid-19 tests_19062020132 KB
|
39 |
Biomed Diagnostics Pte Ltd
|
Luminex ARIES® SARS-CoV-2 Assay
|
Biomed_Luminex Aries_Provisional Authorisation for Covid-19 tests_19062020132 KB
|
40 |
TODOS MEDICAL SINGAPORE Pte Ltd
|
Kaira 2019-nCoV Detection Kit
|
TODOS_Kaira_Provisional Authorisation for Covid-19 tests_25062020129 KB
|
41 |
All Eights (Singapore) Pte Ltd
|
Hologic Aptima® SARS-CoV-2 assay
|
All Eights_Hologic_Provisional Authorisation for Covid-19 tests_25062020128 KB
|
42 |
Accelerate Technologies Pte Ltd (DxD Hub)
|
Accelerate Technologies Resolute 2.0 assay
|
Accelerate Technologies_Resolute_Provisional Authorisation for Covid-19 tests_25062020133 KB
|
43 |
All Eights (Singapore) Pte Ltd
|
genesig® Real-Time PCR COVID-19 (Swab Use)
|
All Eights_genesig_Provisional Authorisation for Covid-19 tests_27082020103 KB
|
44 |
Andaman Medical Pte Ltd
|
Seegene Allplex™ SARS-CoV-2 Assay
|
Andaman_Seegene_Provisional Authorisation for Covid-19 tests_25062020128 KB
|
45 |
DSO National Laboratories
|
RESOLUTE 1.0 LITE
|
DSO_Resolute 1.0 LITE_Provisional Authorisation for Covid-19 tests_03072020129 KB
|
46 |
EMERGO by UL
|
AccuraDTect SARS-CoV-2 RT-qPCR Kit
|
Emergo_AccuraDTect_Provisional Authorisation for Covid-19 tests_03072020128 KB
|
47 |
Vela Operations Singapore Pte Ltd
|
ViroKey™ SARS-CoV-2 RT-PCR Test v2.0
|
Vela_ViroKey_Provisional Authorisation for Covid-19 tests_03072020130 KB
|
48 |
Biotrilance Pte Ltd
|
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
|
Biotrilance_Novel_Provisional Authorisation for Covid-19 tests_09072020134 KB
|
49 |
JN Medsys Pte Ltd
|
ProTect COVID-19 RT-qPCR Kit 2.0
|
JN Medsys_ProTect_Provisional Authorisation for Covid-19 tests_09072020129 KB
|
50 |
AMT Pte Ltd
|
AMT Resolute 2.0 assay
|
AMT_Resolute 2.0_Provisional Authorisation for Covid-19 tests_09072020125 KB
|
51 |
An Xin Home Care
|
genesig® Real-Time PCR Coronavirus COVID-19
|
An Xin_genesig_Provisional Authorisation for Covid-19 tests_28072020128 KB
|
52 |
Life Technologies Holdings Pte Ltd
|
TaqPath™ COVID 19 CE IVD RT PCR Kit
|
Life Technologies_TaqPath_Provisional Authorisation for Covid-19 tests_28072020136 KB
|
53 |
BioMérieux Singapore Pte Ltd
|
BioFire® Respiratory Panel 2.1 plus (RP2.1plus)
|
BioMérieux_BioFire_Provisional Authorisation for Covid-19 tests_28072020131 KB
|
54 |
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
|
55 |
Restalyst Pte Ltd
|
genesig® Real-Time PCR COVID-19 (Swab Use)
|
Restalyst_genesig_Provisional Authorisation for Covid-19 tests_18082020130 KB
|
56 |
Gaia Science Pte Ltd
|
genesig® Real-Time PCR COVID-19 (Swab Use)
|
Gaia_genesig_Provisional Authorisation for Covid-19 tests_18082020131 KB
|
57 |
Veredus Laboratories Pte Ltd
|
VereRT™ ZeroPrep™ COVID-19 PCR Kit
|
Veredus_VereRT™ ZeroPrep™_Provisional Authorisation for Covid-19 tests_07122020103 KB
|
58 |
Link Trust Laboratories Pte Ltd
|
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection kit
|
Linktrust_DiaPlexQ_Provisional Authorisation for Covid-19 tests_18082020137 KB
|
59 |
Illumina Singapore Pte Ltd
|
Illumina COVIDSeq Test
|
Illumina_COVIDSeq Test_Provisional Authorisation for Covid-19 tests_25122020102 KB
|
60 |
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
|
61 |
AGSG
|
COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit
|
AGSG_COVID-19 (SARS-CoV-2)_Provisional Authorisation for Covid-19 tests_08092020101 KB
|
62 |
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
|
63 |
Cellbae Pte Ltd
|
TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit
|
Cellbae_TEPAT_Provisional Authorisation for Covid-19 tests_17092020102 KB
|
64 |
Abbott Laboratories (S) Pte Ltd
|
Abbott Alinity m SARS-CoV-2 AMP Kit
|
Abbott_Alinity m_Provisional Authorisation for Covid-19 tests_17092020103 KB |
65 |
QuikPath Pte Ltd
|
QuikPath SARS-CoV-2 Isothermal RT- PCR Kit
|
QuikPath_SARS-CoV-2 Isothermal _Provisional Authorisation for Covid-19 tests_17092020101 KB
|
66 |
Acumen Research Laboratories Pte Ltd
|
Satugen Solo
|
Acumen_Satugen Solo_Provisional Authorisation for Covid-19 tests_23092020100 KB
|
67 |
Acumen Research Laboratories Pte Ltd
|
Acu-Corona Solo
|
Acumen_Acu-Corona Solo_Provisional Authorisation for Covid-19 tests_23092020100 KB
|
68 |
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
|
69 |
Anomalous Materials Pte Ltd
|
2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
|
Anomalous_Triplex RT-qPCR_Provisional Authorisation for Covid-19 tests_14102020101 KB
|
70 |
Veredus Laboratories Pte Ltd
|
VereCoV™ OneMix Detection Kit
|
Veredus_VereCoV™ OneMix_Provisional Authorisation for Covid-19 tests_14102020101 KB
|
71 |
Genome Institute of Singapore
|
3S SARS-CoV-2 RT-PCR Kit
|
GIS_3S SARS-CoV-2 RT-PCR_Provisional Authorisation for Covid-19 tests_14102020103 KB
|
72 |
TODOS Medical Singapore Pte Ltd
|
Zybio SARS-CoV-2 Nucleic Acid Detection Kit
|
TODOS_Zybio_Provisional Authorisation for Covid-19 tests_31102020101 KB
|
73 |
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
|
Antigen Tests |
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_28072020135 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_24102020102 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
|
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 SARS-CoV-2 Antibody Test (Lateral Flow Method) |
SkyQuest_Wondfo_Provisional Authorisation for Covid-19 tests_17072020135 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 SARS-CoV-2 Antibody Test (Lateral Flow Method) |
Bioforge_Wondfo_Provisional Authorisation for Covid-19 tests_05052020447 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 IgG_Provisional Authorisation for Covid-19 tests_02062020127 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 IgA_Provisional Authorisation for Covid-19 tests_02062020126 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)
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Siemens_Atellica_Provisional Authorisation for Covid-19 tests_02062020129 KB
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30 |
Siemens Healthcare Pte Ltd
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Siemens ADVIA Centaur® SARS-CoV-2 Total (COV2T)
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Siemens_ADVIA_Provisional Authorisation for Covid-19 tests_02062020129 KB
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31 |
Ortho Clinical Diagnostics
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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
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Ortho Clinical_VITROS_Provisional Authorisation for Covid-19 tests_08062020143 KB
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32 |
Alcotech Pte Ltd
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2019-nCoV IgG/IgM Rapid Test Cassette
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Alcotech_2019-nCoV_Provisional Authorisation for Covid-19 tests_08062020131 KB
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33 |
Unison Collaborative Pte Ltd
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RightSign COVID-19 IgG/IgM Rapid Test Cassette
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Unison_RightSign_Provisional Authorisation for Covid-19 tests_12062020131 KB
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34 |
Bio-Rad Laboratories (Singapore) Pte Ltd
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Biorad Platelia SARS-CoV-2 Total Ab
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Biorad_Platelia_Provisional Authorisation for Covid-19 tests_25062020128 KB
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35 |
Beckman Coulter Singapore Pte Ltd
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ACCESS SARS-CoV-2 IgG
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Beckman Coulter_Access_Provisional Authorisation for Covid-19 tests_03072020128 KB
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36 |
ZMC Technologies Pte Ltd
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Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Test Kit (Colloidal Gold)
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ZMC_nCoV_Provisional Authorisation for Covid-19 tests updated_09072020136 KB
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37 |
Unison Collaborative Pte Ltd
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Panbio™ COVID-19 IgG/IgM Rapid Test Device
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Unison_Panbio_Provisional Authorisation for Covid-19 tests_25062020137 KB
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38 |
RAS Pharma and Biochem Pte Ltd
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RAS Rapid Test - 2019-nCov IgG/IgM Rapid Test
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RAS Pharma_RAS Rapid_Provisional Authorisation for Covid-19 tests_25062020133 KB
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39 |
Cell ID Pte Ltd
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Smart COVID-19 IgM-IgG Rapid Diagnostic Test
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Cell ID_Smart_Provisional Authorisation for Covid-19 tests_03072020132 KB
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40 |
Restalyst Pte Ltd
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RAPIT COVID-19 IgM/IgG Test Kit
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Restalyst_Rapit_Provisional Authorisation for Covid-19 tests_03072020131 KB
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41 |
Genomax Technologies Pte Ltd
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Hangzhou Lysun 2019-nCoV IgG/IgM Rapid Test Device
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Genomax_Hangzhou Lysun_Provisional Authorisation for Covid-19 tests_09072020133 KB
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42 |
Siemens Healthcare Pte Ltd
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Siemens Atellica® IM SARS-CoV-2 IgG (COV2G)
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Siemens_Atellica_Provisional Authorisation for Covid-19 tests_17072020132 KB
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43 |
Siemens Healthcare Pte Ltd
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Siemens ADVIA Centaur® SARS-CoV-2 IgG (COV2G)
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Siemens_ADVIA Centaur_Provisional Authorisation for Covid-19 tests_17072020132 KB
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44 |
EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.
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EUROIMMUN Anti-SARS-CoV-2 NCP ELISA (IgG)
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EUROIMMUN_NCP_Provisional Authorisation for Covid-19 tests_06082020133 KB
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45 |
Restalyst Pte Ltd
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Restalyst COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA
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Restalyst_COVID19N_Provisional Authorisation for Covid-19 tests_18082020139 KB
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46 |
Nova Diagnostics Pte Ltd
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MAGLUMI 2019-nCoV IgG (CLIA)
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Nova Diagnostics_MAGLUMI IgG_Provisional Authorisation for Covid-19 tests_2108202099 KB
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47 |
Nova Diagnostics Pte Ltd
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MAGLUMI 2019-nCoV IgM (CLIA)
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Nova Diagnostics_MAGLUMI IgM_Provisional Authorisation for Covid-19 tests_2108202099 KB
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48 |
Alcotech Pte Ltd
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FaStep COVID-19 IgG/IgM Rapid Test Device
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Alcotech_FaStep_Provisional Authorisation for Covid-19 tests_01092020103 KB
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49 |
Abbott Laboratories (S) Pte Ltd
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Abbott ARCHITECT SARS-CoV-2 IgM
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Abbott_ARCHITECT SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_08092020101 KB
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50 |
Abbott Laboratories (S) Pte Ltd
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ABBOTT Alinity i SARS-CoV-2 IgM |
Abbott_Alinity i SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_08092020101 KB
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51 |
bioMérieux Singapore Pte Ltd
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VIDAS® SARS-COV-2 IgG
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bioMérieux_VIDAS® IgG_Provisional Authorisation for Covid-19 tests_14102020103 KB
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52 |
bioMérieux Singapore Pte Ltd
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VIDAS® SARS-COV-2 IgM
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bioMérieux_VIDAS® IgM_Provisional Authorisation for Covid-19 tests_14102020103 KB
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53 |
All Eights (Singapore) Pte Ltd
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Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture)
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All Eights_Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture)_Provisional Authorisation for Covid-19 tests_14102020141 KB
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54 |
All Eights (Singapore) Pte Ltd
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Ansh Labs SARS-CoV2 IgG ELISA
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All Eights_Ansh Labs SARS-CoV2 IgG ELISA_Provisional Authorisation for Covid-19 tests_14102020101 KB
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55 |
Roche Diagnostics Asia Pacific Pte Ltd
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Roche Elecsys Anti-SARS-CoV-2 S
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Roche_Elecsys Anti-SARS-CoV-2 S_Provisional Authorisation for Covid-19 tests_14102020102 KB
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56 |
ZMC Technologies Pte Ltd
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ichroma™ COVID-19 Ab
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ZMC_ichroma™ COVID-19 Ab_Provisional Authorisation for Covid-19 tests_21112020100 KB
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57 |
Biomed Diagnostics Pte Ltd
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SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay)
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Biomed_SARS-CoV-2 IgG_Provisional Authorisation for Covid-19 tests_07122020100 KB
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58 |
Biomed Diagnostics Pte Ltd
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SARS-CoV-2 IgM (Electrochemiluminescence Immunoassay)
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Biomed_SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_07122020100 KB
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59 |
Beckman Coulter Singapore Pte Ltd
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ACCESS SARS-CoV-2 IgM
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Beckman Coulter_ACCESS SARS-CoV-2 IgM_Provisional Authorisation for Covid-19 tests_13122020107 KB
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