PRODUCT EVALUATION STATUS SELF-ADMINISTERED ANTIGEN TEST KITS

Updated as of 13 May 2022

NoProduct NameManufacturerSTATUS
1COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) (Nasal)Anhui DeepBlue Medical TechnologySTAGE 3
Ongoing
2Quidel QuickVue At-Home OTCQuidel CorporationSTAGE 3
With further requirements
3VivaDiag PRO SARS-COV-2 Ag Rapid TestVivaCheck Biotech (Hangzhou) Co., Ltd.STAGE 2
With further submission
4Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (Self testing)Guangzhou Wondfo Biotech Co., Ltd.STAGE 1
For completion of requirements
5PARTNERS COVID- 19 ANTIGEN RAPID TEST KIT (Nasal swab) (for Home or Self Administered Kit)Hangzhou Biotest Biotech Co., Ltd.STAGE 1
With further requirements
6V-Check-2019-nCoV Ag Rapid Test Kit (Immunochromatography)Guangzhou Decheng Biotechnology Co. Ltd.STAGE 1
Ongoing technical assessment
7GLINE-2019-nCoV AgShenzhen Yhlo Biotech Co., LTDSTAGE 1
Ongoing technical assessment
8SGTi-flex Covid-19 Ag Self-TestSUGENTECH, INC.STAGE 1
Ongoing technical assessment/ with further requirement
9SD Biosensor STANDARD Q COVID-19 Ag Home Test
(Self testing)
SD Biosensor, Inc.STAGE 1
Ongoing technical assessment/ with further requirement
10COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay)Lansion Biotechnology Co., Ltd.STAGE 1
Ongoing technical assessment/ with further requirement
11Ecotest COVID-19 Antigen Nasal Test Kit
(Self test kit)
Assure Tech. (Hangzhou) Co., Ltd.STAGE 1
Ongoing technical assessment
12COVID-19 Self-Administered Rapid Antigen TestZybio Inc.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
13Clintest Rapid COVID-19 Antigen Self TestHealgen Scientific Limited Liability CompanySTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
14COVID-19 Antigen Nasal Test Kit FASTEPAssure Tech HangzhouSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
15CLUNGENE COVID-19 ANTIGEN RAPID TEST CASSETTE - (Self Testing)Hangzhou Clongene Biotech Co., Ltd,STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
16COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) (Saliva)Anhui Deepblue Medical TechnologySTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
17SARS-CoV-2 Antigen Test Kit (Colloidal Method)Genrui Biotech Inc.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
18SARS-CoV-2 Antigen Rapid Tests for Self TestingBeijing Lepu Medical Technology Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
19Biocredit Covid-19 Ag Home Test Nasal (Self-Testing)RapiGEN, Inc.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
20SARS CoV-2 Antigen Rapid Test (Nasal Swab) (for self Testing)
INCP-502H
Hangzhou AllTest Biotech Co., LtdSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
21Strongstep x Crazydoctor SARS-COV-2 Antigen Rapid Test (Nasal swab) (Self-Testing)Nanjing Liming Bio-Products Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
22LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (colloidal Gold) for Self TestingHangzhou Laihe Biotech Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
23GeneFinder COVID-19 Ag Self-TestOSANG HEALTHCARESTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
24Coronavirus (2019-nCoV)-Antigentest (Self testing)BEIJING HOTGEN BIOTECH CO., LTD.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
25Beright SARS-CoV-2 Antigen Rapid Test (Nasal) Self-testHangzhou Alltest Biotech Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
26COVID-19 Self-Administered Rapid Antigen TestXiamen Boson Biotech Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
27Covid-19 Antigen Rapid test kit (Swab) Self Testing)Safecare Biotech (Hangzhou) Co., LtdSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
28SARS-CoV-2 Antigen Rapid tests for self-testingAssure Tech. (Hangzhou) Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
29SARS-Cov-2 Antigen Test Kit (LFIA)Jiangsu Medomics Medical Technology Co., LtdSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
30SARS-CoV-2 Antigen Rapid Test Cassette
(Self-testing)
Beijing Applied Biological Technologies Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
31Lucira Check-IT Covid-19 Test KitLucira Health, IncSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
32COVID-19 Ag Antigenic Self-Testing KitEurobio ScientificSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
33SARS-CoV-2 Ag Self Test Kit (Nasal Swab)Shenzhen Watmind Medical Co., LtdSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
34CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self Test)Shenzhen CAS-Envision Medical Technology Co., LtdSTAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
35Rightsign Covid- 19 Antigen Rapid Test Cassette (Nasal swab) (for Self-testing)Hangzhou Biotest Biotech Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
36COVID -19 ANTIGEN DETECTION KIT (COLLOIDAL GOLD)Zhuhai Lituo Biotechnology Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
37COVID-19 Antigen Rapid Test (Colloidal Gold) Anterior Nasal- Self testing DeviceJoinstar Biomedical Technology Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
38BD Kit for Rapid Detection of SARS-COV-2Becton, Dickinson and Company (BD)STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
39LIFOTRONIC SARS-CoV-2 ANTIGEN SELF-TEST – NASALShenzhen Lifotronic Technology Co., Ltd.STAGE 1
Endorsed to technical team. Kindly await email notice for further instructions
40Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-Test)Jiangsu Bioperfectus Technologies Co., LtdSTAGE 1
For completeness of documentary requirements