Xiamen Biotime Biotechnology Company · 89-08 · CHINA
For Xiamen Biotime Biotechnology Company · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST | INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test | Innova COVID-19 Self-Test kit | SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST | BIOTIME SARS-CoV-2 Antigen Rapid Qualitative Test; product code is 83 L - - IB Device, General Purpose, Microbiology, Diagnostic | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 03/02/2021; address is F 2 F 3 , 4f Pingcheng South Road, Haicang Street; Haicang District , Xiamen, Fujian CHINA, verified against its source on 2026-09-16.
- Firm
- Xiamen Biotime Biotechnology Company verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- F 2 F 3 , 4f Pingcheng South Road, Haicang Street; Haicang District , Xiamen, Fujian CHINA verified
- Date published
- 03/02/2021 verified
- Product code
- 83 L - - IB Device, General Purpose, Microbiology, Diagnostic | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST | INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test | Innova COVID-19 Self-Test kit | SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST | BIOTIME SARS-CoV-2 Antigen Rapid Qualitative Test each item verified
What the source says
Xiamen Biotime Biotechnology Company Date Published : 03/02/2021 F 2 F 3 , 4f Pingcheng South Road, Haicang Street; Haicang District , Xiamen, Fujian CHINA 83 L - - IB Device, General Purpose, Microbiology, Diagnostic Date Published: 03/02/2021 Desc: SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST Notes: 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/20/2021 Desc: INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/20/2021 Desc: Innova COVID-19 Self-Test kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 03/02/2021 Desc: SARS-COV-2 ANTIGEN RAPID QUALITATIVE TEST Notes: 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/20/2021 Desc: BIOTIME SARS-CoV-2 Antigen Rapid Qualitative Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html