MedMira Laboratories Inc. · 89-08 · CANADA
For MedMira 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 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 2026-09-16.
- 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 83 Q - - KO Reagent, coronavirus serological Date Published: 01/29/2021 Desc: REVEALCOVID-19 %u2122 Total Antibody Test
— 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.