BIOGENEX LIFE SCIENCES PVT. LTD. · 89-08 · INDIA
For BIOGENEX LIFE SCIENCES 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 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 listed twice: Plot No.4, Survey #656/A , Hyderabad, INDIA and SURVEY NO. 225 & 226 , INDUSTRIAL DEVELOPMENT AREA - PHASE II , HYDERABAD, INDIA, verified against its source on 2026-09-30.
- 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
- SURVEY NO. 225 & 226 , INDUSTRIAL DEVELOPMENT AREA - PHASE II , HYDERABAD, INDIA also listed
- 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
— accessdata.fda.gov, retrieved 2026-09-22
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: 01/21/2022 Desc: COVID-19 RT-PCR Direct; Nasal Swab Home Collection Kit
— all from accessdata.fda.gov, retrieved 2026-09-22
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
— accessdata.fda.gov, retrieved 2026-09-22
Product code
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 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/13/2022 Desc: BGX COVID-19 RT-PCR
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html