MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED · 89-08 · INDIA
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
- 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. 99-B , Lonavla Industrial Co-Operative Estate Ltd, Nangargaon, Lonavla , Pune, Maharashtra INDIA verified
- Date published
- 05/28/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- PathoCatch COVID-19 Antigen Lateral Flow Test Device verified
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
— 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.