# GENEPATH DIAGNOSTICS INDIA PRIVATE · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For GENEPATH DIAGNOSTICS INDIA PRIVATE · 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 Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA, verified against its source on 2026-09-16.

- **Firm:** GENEPATH DIAGNOSTICS INDIA PRIVATE _(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:** INDIA _(verified: appears in the quote below)_
- **Address:** Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA _(verified: appears in the quote below)_
- **Date published:** 11/24/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** GenePath CoViSwift v3.0 _(verified: appears in the quote below)_

## What the source says

> GENEPATH DIAGNOSTICS INDIA PRIVATE Date Published : 11/24/2021 Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: GenePath CoViSwift v3.0

## 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/).