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Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit - MOL5390
FDA 510(k)Class II (US FDA 510(k))
510(k) DEN230092
Identifiers
- 510(k) Number
- DEN230092 FDA 510(k)
- FDA Product Code
- SBT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3967 FDA 510(k)
- Regulation Number
- 866.3967 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit - MOL5390 by DiaSorin Molecular LLC — Class II — FDA_510K…
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 | DEN230092 | Class II | Active |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
- FDA Applicant
- Diasorin Molecular, LLC
Sources (1)
- FDA 510(k) DEN230092 24 fields · synced Jun 19, 2026