BIOGENEX LIFE SCIENCES PVT. LTD. · 89-08 · INDIA
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
- 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
- Plot No.4, Survey #656/A , Hyderabad, INDIA verified
- Date published
- 01/21/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit verified
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
— accessdata.fda.gov, retrieved 2026-09-15
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
— 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.