# bioLytical Laboratories, Inc. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For bioLytical Laboratories, Inc. · 89-08 · CANADA, 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 CANADA; product is INSTI COVID-19 Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is 13251 Delf Pl Unit 406 , Richmond, British Columbia CANADA, verified against its source on 2026-09-16.

- **Firm:** bioLytical Laboratories, Inc. _(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:** CANADA _(verified: appears in the quote below)_
- **Address:** 13251 Delf Pl Unit 406 , Richmond, British Columbia CANADA _(verified: appears in the quote below)_
- **Date published:** 04/20/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** INSTI COVID-19 Antibody Test _(verified: appears in the quote below)_

## What the source says

> bioLytical Laboratories, Inc. Date Published : 04/20/2022 13251 Delf Pl Unit 406 , Richmond, British Columbia CANADA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: INSTI COVID-19 Antibody Test

## 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/).