# MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED · 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 PathoCatch COVID-19 Antigen Lateral Flow Test Device; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 05/28/2021; address is Plot No. 99-B , Lonavla Industrial Co-Operative Estate Ltd, Nangargaon, Lonavla , Pune, Maharashtra INDIA, verified against its source on 2026-09-16.

- **Firm:** MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED _(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. 99-B , Lonavla Industrial Co-Operative Estate Ltd, Nangargaon, Lonavla , Pune, Maharashtra INDIA _(verified: appears in the quote below)_
- **Date published:** 05/28/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** PathoCatch COVID-19 Antigen Lateral Flow Test Device _(verified: appears in the quote below)_

## What the source says

> MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED Date Published : 05/28/2021 Plot No. 99-B , Lonavla Industrial Co-Operative Estate Ltd, Nangargaon, Lonavla , Pune, Maharashtra INDIA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: PathoCatch COVID-19 Antigen Lateral Flow Test Device

## 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/).