# LAB-CARE DIAGNOSTICS (INDIA) PVT · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For LAB-CARE DIAGNOSTICS (INDIA) PVT · 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 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 2026-09-16.

- **Firm:** LAB-CARE DIAGNOSTICS (INDIA) PVT _(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:** C1 Type Shed No 3225 Ch , Gujarat, INDIA _(verified: appears in the quote below)_
- **Date published:** 03/11/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit _(verified: appears in the quote below)_

## What the source says

> LAB-CARE DIAGNOSTICS (INDIA) PVT Date Published : 03/11/2021 C1 Type Shed No 3225 Ch , Gujarat, INDIA 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: ACCUCARE COVID-19 IgG/IgM Lateral Flow Assay Test Kit

## 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/).