LAB-CARE DIAGNOSTICS (INDIA) PVT · 89-08 · INDIA
For LAB-CARE DIAGNOSTICS (INDIA) PVT, 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 ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is C1 Type Shed No 3225 Ch , Gujarat, INDIA, verified against its source on 2026-09-30.
- Firm
- LAB-CARE DIAGNOSTICS (INDIA) PVT 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
- C1 Type Shed No 3225 Ch , Gujarat, INDIA verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit verified
What the source says
LAB-CARE DIAGNOSTICS (INDIA) PVT Date Published : 03/11/2021 C1 Type Shed No 3225 Ch , Gujarat, 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 - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit
— all from 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.