bioLytical Laboratories, Inc. · 89-08 · CANADA
For bioLytical Laboratories, Inc., import alert is 89-08; country is CANADA; 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 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 2026-09-30.
- Firm
- bioLytical Laboratories, Inc. 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
- CANADA verified
- Address
- 13251 Delf Pl Unit 406 , Richmond, British Columbia CANADA verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- INSTI COVID-19 Antibody Test verified
What the source says
bioLytical Laboratories, Inc. Date Published : 04/20/2022 13251 Delf Pl Unit 406 , Richmond, British Columbia CANADA
— 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: 04/20/2022 Desc: INSTI COVID-19 Antibody Test
— 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.