MOLBIO DIAGNOSTICS PRIVATE · 89-08 · INDIA
For MOLBIO DIAGNOSTICS PRIVATE · 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 Truenat%u2122 SARS CoV-2 | Truenat%u2122 Beta CoV; 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 2026-09-16.
- 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 SARS CoV-2 | Truenat%u2122 Beta CoV each item verified
What the source says
MOLBIO DIAGNOSTICS PRIVATE Date Published : 10/28/2021 Plot No L - 46 , Mumbai, Maharashtra INDIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/28/2021 Desc: Truenat%u2122 SARS CoV-2 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/28/2021 Desc: Truenat%u2122 Beta CoV
— 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.