MERLIN BIOMEDICAL (XIAMEN) · 89-08 · CHINA
For MERLIN BIOMEDICAL (XIAMEN), import alert is 89-08; country is CHINA; 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)"; product is SARS-CoV-2 Antigen Rapid Test Cassette; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is 4th Floor , Building B3, 2054 West Wengjiao Rd , Haicang , Xiamen, Fujian CHINA, verified against its source on 2026-09-30.
- Firm
- MERLIN BIOMEDICAL (XIAMEN) 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
- 4th Floor , Building B3, 2054 West Wengjiao Rd , Haicang , Xiamen, Fujian CHINA verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- SARS-CoV-2 Antigen Rapid Test Cassette verified
What the source says
MERLIN BIOMEDICAL (XIAMEN) Date Published : 06/22/2021 4th Floor , Building B3, 2054 West Wengjiao Rd , Haicang , Xiamen, Fujian CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: SARS-CoV-2 Antigen Rapid Test Cassette
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html