PFT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reagents For Molecular Diagnostic Test Systems
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3800
- Medical specialty
- Clinical Chemistry
- FDA definition
- 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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| Record | Firm | Date |
|---|---|---|
| MISEQDX UNIVERSAL KIT 1.0 (DEN130042) | Illumina, Inc. | 2013-11-19 |
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