# BIOGENEX LIFE SCIENCES PVT. LTD. · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For BIOGENEX LIFE SCIENCES 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 COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 01/21/2022; address is Plot No.4, Survey #656/A , Hyderabad, INDIA, verified against its source on 2026-09-16.

- **Firm:** BIOGENEX LIFE SCIENCES PVT. LTD. _(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:** Plot No.4, Survey #656/A , Hyderabad, INDIA _(verified: appears in the quote below)_
- **Date published:** 01/21/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit _(verified: appears in the quote below)_

## What the source says

> BIOGENEX LIFE SCIENCES PVT. LTD. Date Published : 01/21/2022 Plot No.4, Survey #656/A , Hyderabad, INDIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/21/2022 Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit

## The same source also states

> BIOGENEX LIFE SCIENCES PVT. LTD. Date Published : 01/21/2022 SURVEY NO. 225 & 226 , INDUSTRIAL DEVELOPMENT AREA - PHASE II , HYDERABAD, INDIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/13/2022 Desc: BGX COVID-19 RT-PCR 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/21/2022 Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## 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/).