Reference Source

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

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

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

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