MedMira Laboratories Inc. · 89-08 · CANADA
For MedMira 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 REVEALCOVID-19 %u2122 Total Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/29/2021; address is Suite 1 Unit 1 , 155 Chain Lake Dr , Halifax, Nova Scotia CANADA, verified against its source on 2026-09-30.
- Firm
- MedMira 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
- Suite 1 Unit 1 , 155 Chain Lake Dr , Halifax, Nova Scotia CANADA verified
- Date published
- 01/29/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- REVEALCOVID-19 %u2122 Total Antibody Test verified
What the source says
MedMira Laboratories Inc. Date Published : 01/29/2021 Suite 1 Unit 1 , 155 Chain Lake Dr , Halifax, Nova Scotia 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: 01/29/2021 Desc: REVEALCOVID-19 %u2122 Total Antibody Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html