Reagents For Molecular Diagnostic Test Systems
- US Product Code (FDA)
- PFTView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 862.3800View CFR Regulation →
- Medical specialty
- Clinical Chemistry
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.
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Reagents For Molecular Diagnostic Test Systems is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.