# MOLBIO DIAGNOSTICS PRIVATE · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Plot No L - 46 , Mumbai, Maharashtra INDIA _(verified: appears in the quote below)_
- **Date published:** 10/28/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: each item appears in the quote below)_
- **Product:** Truenat%u2122 SARS CoV-2 | Truenat%u2122 Beta CoV _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).