ACHIRA LAB PVT LTD · 89-08 · INDIA
For ACHIRA LAB PVT LTD, import alert is 89-08; country is INDIA; 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 GenePath CoViSwift v3.0; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is 66b 13th Cross Rd Dolla , Jp Bengaluru Karnatak, INDIA, verified against its source on 2026-09-30.
- Firm
- ACHIRA LAB PVT 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
- INDIA verified
- Address
- 66b 13th Cross Rd Dolla , Jp Bengaluru Karnatak, INDIA verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- GenePath CoViSwift v3.0 verified
What the source says
ACHIRA LAB PVT LTD Date Published : 11/24/2021 66b 13th Cross Rd Dolla , Jp Bengaluru Karnatak, INDIA
— 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: GenePath CoViSwift v3.0
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.