Reference Source

ACHIRA LAB PVT LTD · 89-08 · INDIA

For ACHIRA LAB PVT LTD · 89-08 · INDIA, 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 INDIA; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

ACHIRA LAB PVT LTD Date Published : 11/24/2021 66b 13th Cross Rd Dolla , Jp Bengaluru Karnatak, INDIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: GenePath CoViSwift v3.0

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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