PFT — Reagents For Molecular Diagnostic Test Systems Class I
FDA product code PFT covers "Reagents For Molecular Diagnostic Test Systems", a Class I medical device regulated under 21 CFR 862.3800. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PFT
- Device Class
- Class I
- Regulation Number
- 862.3800
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN130042 | illumina | MISEQDX UNIVERSAL KIT 1.0 | November 19, 2013 |