BIOCAN DIAGNOSTICS INC · 89-08 · CANADA
For BIOCAN DIAGNOSTICS 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 Tell Me Fast Novel Coronavirus (COVID19) IgG/IgM Antibody Test Strip | Tell Me Fast; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2021; address is 55a & 53b Fawcett Road , Coquitlam, British Columbia CANADA, verified against its source on 2026-09-30.
- Firm
- BIOCAN DIAGNOSTICS 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
- 55a & 53b Fawcett Road , Coquitlam, British Columbia CANADA verified
- Date published
- 04/20/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Tell Me Fast Novel Coronavirus (COVID19) IgG/IgM Antibody Test Strip | Tell Me Fast each item verified
What the source says
BIOCAN DIAGNOSTICS INC Date Published : 04/20/2021 55a & 53b Fawcett Road , Coquitlam, British Columbia CANADA
— accessdata.fda.gov, retrieved 2026-09-22
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: 04/20/2021 Desc: Tell Me Fast Novel Coronavirus (COVID19) IgG/IgM Antibody Test Strip 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2021 Desc: Tell Me Fast
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html