PFT · Reagents For Molecular Diagnostic Test Systems
Clinical Chemistry · 21 CFR 862.3800 · Class 1
Overview
| Product Code | PFT |
|---|---|
| Device Name | Reagents For Molecular Diagnostic Test Systems |
| Regulation | 21 CFR 862.3800 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
Reagents for molecular diagnostic test systems are reagents other than analyte specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together, and labeled nucleic acid molecules.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedure in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN130042 | MISEQDX UNIVERSAL KIT 1.0 | Illumina, Inc. | Nov 19, 2013 | DENG |
Top Applicants
- Illumina, Inc. — 1 clearance
