Updated as of 15 September 2022

NoProduct NameManufacturerStatus
1Resolute 2.0 (SARS-CoV-2 Direct Detection Kit (REF: CK02-02, CK03-02)Alliance Biomed Pte LtdStage 4
For approval and transmittal to FDA
2SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)Sansure Biotech Inc.Stage 3
On-hold. Awaiting Replacement kit
3Zybio SARS-CoV-2 Assay KitZybio IncStage 3
Ongoing
4Molaccu Fast SARS-CoV-2 RT-qPCR Detection KitZybio IncStage 3
Ongoing
5Molaccu RT-PCR COVID-19 Test KitZybio Inc.Stage 2
For payment
6SARS-COV-2 (COVID-19)/ Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR Method)HUNAN RUNMEI GENE TECHNOLOGY CO.,LTDStage 2
For payment and delivery
7Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)Sansure Biotech Inc.Stage 2
For payment
8ANDis SARS-CoV-2 and Influenza A/B RT-qPCR Detection Kit3D Biomedicine Science & Technology Co., LimitedStage 1
Awaiting schedule. Please wait for email instructions.
9OPTI SARS-CoV-2/ Influenza A/B RT-PCR TestOPTI Medical Systems, IncStage 1
Awaiting schedule. Please wait for email instructions.
10SARS-COV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)Zybio IncStage 1
Awaiting schedule. Please wait for email instructions.
11DirectDetectTM SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) (NL-CA002-2020-49934)Coyote Bioscience Co., LtdStage 1
For Technical Review