MACCURA BIOTECHNOLOGY CO LTD · 89-08 · CHINA
For MACCURA BIOTECHNOLOGY CO LTD, 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 Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/29/2021; address is No. 8 Anhe No.2 Rd. , Hi-Tech Zone , Chengdu, Sichuan CHINA, verified against its source on 2026-09-30.
- Firm
- MACCURA BIOTECHNOLOGY CO LTD 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
- No. 8 Anhe No.2 Rd. , Hi-Tech Zone , Chengdu, Sichuan CHINA verified
- Date published
- 01/29/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method verified
What the source says
MACCURA BIOTECHNOLOGY CO LTD Date Published : 01/29/2021 No. 8 Anhe No.2 Rd. , Hi-Tech Zone , Chengdu, Sichuan 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 - - KO Reagent, coronavirus serological Date Published: 01/29/2021 Desc: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html