# Xiamen Biotime Biotechnology Company · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** F 2 F 3 , 4f Pingcheng South Road, Haicang Street; Haicang District , Xiamen, Fujian CHINA _(verified: appears in the quote below)_
- **Date published:** 03/02/2021 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).