Effective January 1, 2022, only HSA-registered or PSAR authorized COVID – 19 test kits will be listed on the Singapore Medical Device Register (SMDR) and are allowed for supply in Singapore. For test kits that are not yet registered but are clinically needed, the Ministry of Health (MoH) categorizes these as “emergency medical devices and Professional Use Only (PUO) kits. PUO products will need further evaluation from HSA.

The following PUO test kits are HSA-authorized under the PSAR. They will be supplied to healthcare institutions, private hospitals, medical clinics, or clinical laboratories that are licensed under the Private Hospitals and Medical Clinics (PHMC) Act:

Molecular Tests

PUO Test

Distributor

Authorization Date

Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit 1.0515 KB

SDT Molecular Pte Ltd

16/11/2021

Veredus VereCoV™ OneMix Detection Kit2665 KB

Veredus Laboratories Pte. Ltd.

16/11/2021

PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay1301 KB

PerkinElmer Singapore Pte Ltd

30/11/2021

JN Medsys ProTect™ COVID-19 RT-qPCR kit 2.02101 KB

JN Medsys

30/11/2021

BioFire® Respiratory Panel 2.1 (RP2.1)1290 KB

bioMérieux Singapore Pte Ltd

30/11/2021

BioFire® Respiratory Panel 2.1 plus (RP2.1 plus)1337 KB

bioMérieux Singapore Pte Ltd

30/11/2021

Cepheid Xpert® Xpress SARS-CoV-21485 KB

SPD Scientific Pte Ltd

30/11/2021

Abbott Alinity m SARS-CoV-2 AMP Kit1188 KB Abbott Laboratories (Singapore) Pte. Ltd 30/11/2021
Veredus VereRT™ COVID-19 PCR Kit865 KB Veredus Laboratories Pte. Ltd. 30/11/2021
MiRXES Fortitude Kit 2.11339 KB MiRXES Pte Ltd 8/12/2021
MiRXES Fortitude Kit 3.02722 KB MiRXES Pte Ltd 8/12/2021
Hologic Aptima SARS-CoV-2 Assay488 KB All Eights (S) Pte Ltd 9/12/2021
Life Technologies TaqPath COVID-19 Combo Kit626 KB Life Technologies Holdings Pte. Ltd. 16/12/2021
Acumen Acu-Corona Duplex1256 KB Acumen Research Laboratories Pte Ltd 16/12/2021
Acumen Acu-Corona 2.01541 KB Acumen Research Laboratories Pte Ltd 27/12/2021
QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel1419 KB Qiagen Singapore Pte. Ltd. 31/12/2021

Antigen Tests

PUO Test

Distributor

Authorization Date

Roche Diagnostics Elecsys SARS-CoV-2 Antigen251 KB

Roche Diagnostics Asia Pacific Pte Ltd

30/11/2021

BD Veritor™ System for Rapid Detection of SARS-CoV- 2 (256082, 256089)1105 KB

Becton Dickinson Holding Ptd Ltd

9/12/2021

BD Kit for Rapid Detection of SARS-CoV-2 (256091, 256113, 256114)4556 KB

Becton Dickinson Holding Ptd Ltd

9/12/2021

SD Biosensor Standard Q COVID-19 Ag3008 KB

SPD Scientific Pte Ltd

31/12/2021

PHASE Scientific INDICAID® COVID-19 Rapid Antigen Test396 KB

SDT Molecular Pte Ltd

24/01/2022

Antibody (Serology) Tests

PUO Test

Distributor

Authorization Date

GENSCRIPT cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit942 KB

Genscript Biotech (Singapore) Pte. Ltd.

30/11/2021

bioMérieux VIDAS® SARS-COV-2 IgM312 KB bioMérieux Singapore Pte Ltd

24/12/2021

Abbott Alinity i SARS-CoV-2 IgM1281 KB Abbott Laboratories (Singapore) Pte Ltd 29/12/2021
Restalyst COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA460 KB Restalyst Pte Ltd 29/12/2021
Beckman Coulter Access SARS-CoV-2 IgG291 KB Beckman Coulter Singapore Pte Ltd 31/12/2021
Beckman Coulter Access SARS-CoV-2 IgM292 KB Beckman Coulter Singapore Pte Ltd 31/12/2021


Other Tests

PUO Test

Distributor

Authorization Date

Silver Factory Technology TracieX Breathalyser (Version 2.0.)1355 KB

Silver Factory Technology Pte Ltd

18/01/2022

References:
 COVID-19 Test Kits Authorized for Professional Use

分享: