510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PFTClass I

Reagents For Molecular Diagnostic Test Systems

21 CFR 862.3800 / Clinical Chemistry
FDA source (opens on fda.gov)

PFT is the FDA product code for Reagents For Molecular Diagnostic Test Systems, a class I device type, regulated under 21 CFR 862.3800. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PFT
Device name
Reagents For Molecular Diagnostic Test Systems
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.
Regulation
21 CFR 862.3800
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
2

Clearances, product code PFT

By decision year
1 clearance under product code PFT with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFT by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFT
Applicants holding the most 510(k) clearances under product code PFT
ApplicantClearances
Illumina, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code