Updated as of 15 November 2022

NoProduct NameManufacturerSTATUS
1SARS CoV-2 Antigen Rapid Test (Nasal Swab) (for self Testing)
INCP-502H
Hangzhou AllTest Biotech Co., LtdSTAGE 4
For approval and transmittal
2CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self Test)Shenzhen CAS-Envision Medical Technology Co., LtdSTAGE 2
For payment and delivery
3Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-Test)Jiangsu Bioperfectus Technologies Co., LtdSTAGE 2
For payment and delivery
4Healgen Rapid Covid-19 Antigen Self TestHealgen Scientific Limited Liability CompanySTAGE 1
Ongoing initial technical assessment. With further requirement
5Biobase Covid-19 Antigen Rapid Test
(Self test kit)
Biobase Diagnostic Technology (Shandong) Co., Ltd.STAGE 1
Ongoing initial technical assessment. With further requirement
6Rapid SARS-COV-2 Antigen Test Card Self-test
Ref: A7AG6001BS, A7AG6005BS, 07AG6020BS
MP Biomedicals Germany GmBHSTAGE 1
Ongoing initial technical assessment. With further requirement
7Medriva COVID-19 Rapid Antigen Test (self-testing)ProcureNet APAC Pty. LtdSTAGE 1
Ongoing initial technical assessment. With further requirement
8SARS-CoV-2 Antigen Test
(self-testing kit)
Wuxi Techstar Technology Co., LtdSTAGE 1
Ongoing initial technical assessment. With further requirement
9GENEDIA W COVID-19 AgGreen Cross Medical Science CorporationSTAGE 1
Ongoing initial technical assessment. With further requirement
10COVID-19 Antigen Test Kit for Saliva (Dry Color Latex Immunoassay)
Self test kit
Lansion Biotechnology Co., Ltd.STAGE 1
Ongoing initial technical assessment. With further requirement
11INDICAID COVID-19 Rapid Antigen At-Home Test
Ref P0079, P0080, P0081, P0082
PHASE Scientific International LimitedSTAGE 1
Ongoing initial technical assessment
12PerkinElmer® COVID-19 Antigen Test (Self testing)
Ref. 706050001
Viola Diagnostic Systems –
A Division of Tulip Diagnostics (P) Ltd.
STAGE 1
Ongoing initial technical assessment. With further requirement
13SaliCOV™ Test Kit (Saliva COVID-19 Test) SaliCOV Corona saliva testSalignostics LtdSTAGE 1
Ongoing initial technical assessment. With further requirement
14Verino Pro SARS-COV-2 Ag Rapid Test (Self-test)VivaCheck Biotech (Hangzhou) Co., Ltd.STAGE 1
Ongoing initial technical assessment.
15CoviFind Covid-19 Antigen Self TestMeril Diagnostics Pvt. Ltd.STAGE 1
Ongoing initial technical assessment. With further requirement
16BioTeke SARS-CoV-2 Antigen Test Kit (self testing)BioTeke Corporation (Wuxi) Co., LtdSTAGE 1
Initial Assessment. For completion of requirements
17Partners 2019- nCov Antigen Rapid Test Kit (Colloidal Gold Assay) (self-testing kit)Beijing Diagreat Biotechnologies Co., LtdSTAGE 1
Incomplete
18SARS-CoV 2 Antigen Assay Kit (Colloidal Gold Method)
(Self test kit)
REF 2061702, REF 2061703, REF 2061704
Zybio, IncSTAGE 1
Incomplete
19COVID -19 ANTIGEN DETECTION KIT (COLLOIDAL GOLD)Zhuhai Lituo Biotechnology Co., Ltd.STAGE 1
Incomplete
20SARS-CoV-2 Antigen Rapid Test Device (Self Testing)Zhunai Encode Medical Engineering Co., LtdSTAGE 1
Incomplete