Updated as of 30 September2022

NoProduct NameManufacturerSTATUS
1COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay)Lansion Biotechnology Co., Ltd.STAGE 4
For approval and transmittal to FDA
2SARS-CoV-2 Ag Self Test Kit (Nasal Swab)Shenzhen Watmind Medical Co., LtdSTAGE 4
For approval and transmittal to FDA
3Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (Self testing)Guangzhou Wondfo Biotech Co., LtdSTAGE 4
For approval and transmittal to FDA
4Rightsign Covid- 19 Antigen Rapid Test Cassette (Nasal swab) (for Self-testing)Hangzhou Biotest Biotech Co., Ltd.STAGE 4
For approval and transmittal to FDA
5Panbio COVID-19 Ag Rapid Test Device (NASAL) (with update)Legal Manufacturer: Abbott Rapid Dianostics Jena GmbH
Manufacturer: Abbott Diagnostics Korea
STAGE 4
For approval and transmittal to FDA
6COVID-19 Ag Antigenic Self-Testing KitEurobio ScientificSTAGE 3
Ongoing completion of report
7Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (Self testing)Guangzhou Wondfo Biotech Co., LtdSTAGE 2
For payment and delivery
8SARS-CoV 2 Antigen Assay Kit (Colloidal Gold Method)
(Self test kit)
REF 2061702, REF 2061703, REF 2061704
Zybio, IncSTAGE 2
For payment and delivery
9JusChek COVID-19 Antigen Rapid Test Cassette (Oral Fluid) self-test
Ref: ICOV-802H
Hangzhou Alltest Biotech Co., LtdSTAGE 2
For payment and delivery
10COVID-19 Antigen Rapid Test (Colloidal Gold) Anterior Nasal- Self testing DeviceJoinstar Biomedical Technology Co., Ltd.STAGE 2
For payment and delivery
11SARS CoV-2 Antigen Rapid Test (Nasal Swab) (for self Testing)
INCP-502H
Hangzhou AllTest Biotech Co., LtdSTAGE 1
Ongoing technical assessment. With further requirement
12Beright SARS-CoV-2 Antigen Rapid Test (Nasal) Self-testHangzhou Alltest Biotech Co., Ltd.STAGE 1
Ongoing technical assessment. With further requirement
13CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self Test)Shenzhen CAS-Envision Medical Technology Co., LtdSTAGE 1
Ongoing technical assessment. With further requirement
14COVID -19 ANTIGEN DETECTION KIT (COLLOIDAL GOLD)Zhuhai Lituo Biotechnology Co., Ltd.STAGE 1
Ongoing technical assessment
15Genesea SARS-COV-2 Antigen Rapid Test (Nasal) (Self testing kit)Hangzhou Genesea BiotechnologySTAGE 1
Ongoing technical assessment. With further requirement
16Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-Test)Jiangsu Bioperfectus Technologies Co., LtdSTAGE 1
Ongoing technical assessment
17Healgen Rapid Covid-19 Antigen Self TestHealgen Scientific Limited Liability CompanySTAGE 1
Ongoing technical assessment
18SARS-CoV-2 Antigen Rapid Test Device (Self Testing)Zhunai Encode Medical Engineering Co., LtdSTAGE 1
Ongoing technical assessment
19Biobase Covid-19 Antigen Rapid Test
(Self test kit)
Biobase Diagnostic Technology (Shandong) Co., Ltd.STAGE 1
Ongoing technical assessment
20Rapid SARS-COV-2 Antigen Test Card Self-test
Ref: A7AG6001BS, A7AG6005BS, 07AG6020BS
MP Biomedicals Germany GmBHSTAGE 1
Ongoing technical assessment
21NEWGENE Bioengineering COVID-19 Antigen Detection Kit (Self-test kit)New Gene (Hangzhou) Bioengineering Co., Ltd.STAGE 1
Ongoing technical assessment
22COVID-19 Antigen Detection Kit
(Self test kit)
New Gene (Hangzhou) Bioengineering Co., Ltd.STAGE 1
Queue for technical assessment
23Partners 2019- nCov Antigen Rapid Test Kit (Colloidal Gold Assay) (self-testing kit)Beijing Diagreat Biotechnologies Co., LtdSTAGE 1
Queue for technical assessment
24Medriva COVID-19 Rapid Antigen Test (self-testing)ProcureNet APAC Pty. LtdSTAGE 1
Queue for technical assessment
25SARS-CoV-2 Antigen Test
(self-testing kit)
Wuxi Techstar Technology Co., LtdSTAGE 1
Queue for technical assessment
26GENEDIA W COVID-19 AgGreen Cross Medical Science CorporationSTAGE 1
Queue for technical assessment
27COVID-19 Antigen Test Kit for Saliva (Dry Color Latex Immunoassay)
Self test kit
Lansion Biotechnology Co., Ltd.STAGE 1
Queue for technical assessment
28INDICAID COVID-19 Rapid Antigen At-Home Test
Ref P0079, P0080, P0081, P0082
PHASE Scientific International LimitedSTAGE 1
Queue for technical assessment
29PerkinElmer® COVID-19 Antigen Test (Self testing)
Ref. 706050001
Viola Diagnostic Systems –
A Division of Tulip Diagnostics (P) Ltd.
STAGE 1
Queue for technical assessment
30SaliCOV™ Test Kit (Saliva COVID-19 Test) SaliCOV Corona saliva testSalignostics LtdSTAGE 1
Queue for technical assessment
31Verino Pro SARS-COV-2 Ag Rapid Test (Self-test)VivaCheck Biotech (Hangzhou) Co., Ltd.STAGE 1
Queue for technical assessment
32CoviFind Covid-19 Antigen Self TestMeril Diagnostics Pvt. Ltd.STAGE 1
Queue for technical assessment
33BD Kit for Rapid Detection of SARS-COV-2 (for self-test kit)Becton, Dickinson and CompanySTAGE 1
Incomplete