Reagents For Molecular Diagnostic Test Systems
Device Code: 6011
Product Code(s):
PFT 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 Re
Device Classification Information
| Device Type ID | 6011 |
| Device Name | Reagents For Molecular Diagnostic Test Systems |
| Physical State | Individual Reagents Or Reagent Packages |
| Technical Method | Not Applicable |
| Target Area | Not Applicable |
| Regulation Description | Reagents For Molecular Diagnostic Instrument Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.3800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PFT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6011 |
| Device | Reagents For Molecular Diagnostic Test Systems |
| Product Code | PFT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Reagents For Molecular Diagnostic Instrument Test Systems. |
| CFR Regulation Number | 862.3800 [🔎] |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Horiba Instruments, Inc Dba Horiba Medical | II | Jun-25-2018 |
TPLC Last Update: 2019-04-02 21:16:01