MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED · 89-08 · INDIA
For MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED, 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 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
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 - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: PathoCatch COVID-19 Antigen Lateral Flow Test Device
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html