MOLBIO DIAGNOSTICS PRIVATE · 89-08 · INDIA
For MOLBIO DIAGNOSTICS PRIVATE, 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 Truenat%u2122 Beta CoV | Truenat%u2122 SARS CoV-2; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 10/28/2021; address is Plot No L - 46 , Mumbai, Maharashtra INDIA, verified against its source on 2026-09-30.
- Firm
- MOLBIO DIAGNOSTICS PRIVATE 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 L - 46 , Mumbai, Maharashtra INDIA verified
- Date published
- 10/28/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid each item verified
- Product
- Truenat%u2122 Beta CoV | Truenat%u2122 SARS CoV-2 each item verified
What the source says
MOLBIO DIAGNOSTICS PRIVATE Date Published : 10/28/2021 Plot No L - 46 , Mumbai, Maharashtra 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: 10/28/2021 Desc: Truenat%u2122 Beta CoV 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/28/2021 Desc: Truenat%u2122 SARS CoV-2
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html