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VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, V…
FDA 510(k)Class I (US FDA 510(k))
510(k) K141133
by Biomérieux
Identifiers
- 510(k) Number
- K141133 FDA 510(k)
- FDA Product Code
- LYR FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3110 FDA 510(k)
- Regulation Number
- 866.3110 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, V… by Biomérieux — Class I — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141133 | Class I | Active |
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Manufacturer
- Manufacturer
- Biomérieux
- FDA Applicant
- BIOMERIEUX
Sources (1)
- FDA 510(k) K141133 24 fields · synced Jun 19, 2026