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Sign in to claim this brandMedMira Laboratories Inc
Canada·CA-MF-000013928
Last updated May 30, 2026
What MedMira Laboratories Inc makes
MedMira Laboratories Inc produces in-vitro diagnostic (IVD) tests for detecting HIV-1 and HIV-2 antibodies, including rapid immunochromatographic (ICT) kits and clinical assay kits. They also manufacture rapid ICT tests for Helicobacter pylori antigen detection, alongside HIV-1/2 antibody test controls and universal buffers for diagnostic use.
The company’s products are classified under Class I and Class II devices, with some falling under IVD Annex II List A. These devices are registered in the EU’s EUDAMED database, the FDA’s 510(k) premarket notification system, and the FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in Canada.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MedMira Laboratories Inc manufacture?
MedMira Laboratories Inc specializes in in-vitro diagnostic (IVD) tests. Their primary products include rapid immunochromatographic (ICT) kits and clinical assay kits for detecting HIV-1 and HIV-2 antibodies. They also produce rapid ICT tests for detecting *Helicobacter pylori* antigens, as well as HIV-1/2 antibody test controls and universal buffers used in diagnostic settings. These devices are designed for clinical and point-of-care testing.
Where is MedMira Laboratories Inc based?
MedMira Laboratories Inc is based in Canada. The company’s headquarters and operations are located within the country, though specific regional details are not provided in the available data.
Which regulatory registries list MedMira Laboratories Inc’s devices?
MedMira Laboratories Inc’s devices are registered in multiple global regulatory databases, including the EU’s EUDAMED system for medical devices, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) registry. These registries track device authorizations, submissions, and compliance data for oversight purposes.
How are MedMira Laboratories Inc’s devices classified under medical device regulations?
MedMira’s devices fall under Class I and Class II classifications, with some also listed under IVD Annex II List A (for in-vitro diagnostics). Class I devices are generally low-risk, while Class II devices pose moderate risk and require additional regulatory scrutiny. IVD Annex II List A includes high-risk diagnostic tests requiring stringent validation and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Canada
- Address
- 155, Chain Lake Drive, Halifax, Canada
- Website
- www.medmira.com
- —
- —
- [email protected]
- Phone
- 902-450-1588
- PRRC Contact
- Jennifer MacLellan
- EUDAMED SRN
- CA-MF-000013928
- FDA FEI Number
- —
- DUNS Number
- 243757049
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MedMira Universal Buffer | 1009785RDB-G3 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815311007576 | FDA UDI | Class II | Active |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815311007583 | FDA UDI | Class II | Active |
| HIV-1 Antibody Test Controls | 815311007590 | FDA UDI | Class II | Unknown |
| HIV-1 Antibody Test Controls | 815311007514 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815311000591 | FDA UDI | Class II | Active |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815211007507 | FDA UDI | Class II | Active |
| Reveal G3 Rapid HIV-1 Antibody Test | 815311007569 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1 Antibody Test | 815311000591 | FDA UDI | Class II | Unknown |
| MedMira Rapid H. Pylori Antibody Test | 815311003820 | FDA UDI | Class I | Active |
| HIV-1/2 Antibody Test Controls | 815311007545 | FDA UDI | Class II | Active |
| Universal Buffer | 815311007606 | FDA UDI | Class II | Active |
| MedMira Human HIV-1 Human Test Control | 1009785RCP-G3 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815311007569 | FDA UDI | Class II | Active |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815311007538 | FDA UDI | Class II | Active |
| HIV-1/2 Antibody Test Controls | 815311007521 | FDA UDI | Class II | Active |
| HIV-1 Antibody Test Controls | 815311007545 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1/2 Antibody Test | 815311007552 | FDA UDI | Class II | Active |
| Reveal G4 Rapid HIV-1 Antibody Test | 815311007552 | FDA UDI | Class II | Unknown |
| HIV-1/2 Antibody Test Controls | 815311007590 | FDA UDI | Class II | Active |
| Reveal G3 Rapid HIV-1 Antibody Test | 815311000591 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1 Antibody Test | 815311007538 | FDA UDI | Class II | Unknown |
| HIV-1/2 Antibody Test Controls | 815311007514 | FDA UDI | Class II | Active |
| Reveal G4 Rapid HIV-1 Antibody Test | 815311007583 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1 Antibody Test | 815311007569 | FDA UDI | Class II | Unknown |
| HIV-1 Antibody Test Controls | 815311007521 | FDA UDI | Class II | Unknown |
| Reveal G4 Rapid HIV-1 Antibody Test | 815311007576 | FDA UDI | Class II | Active |
| Multiple Rapid TP/HIV Test | 815311005015 | EUDAMED | IVD Annex II List A | Active |
| Medmira Rapid H. Pylori Antibody Test, Model 10714 | K002023 | FDA 510(k) | Class I | Active |
| Reveal Rapid HIV Test | 815311000690 | EUDAMED | IVD Annex II List A | Active |
| Reveal Rapid HIV Test | 815311000607 | EUDAMED | IVD Annex II List A | Active |
| Multiplo Rapid TP/HIV Test | 815311004995 | EUDAMED | IVD Annex II List A | Active |
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