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

High Throughput Dna Sequence Analyzer

21 CFR 862.2265 / Immunology
FDA source (opens on fda.gov)

PFF is the FDA product code for High Throughput Dna Sequence Analyzer, a class II device type, regulated under 21 CFR 862.2265. FDA's definition for this code reads: "A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
PFF
Device name
High Throughput Dna Sequence Analyzer
FDA definition
A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.
Regulation
21 CFR 862.2265
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
11

Clearances, product code PFF

By decision year
2 clearances under product code PFF with a decision year between 2013 and 2017, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFF by decision year
YearClearances
20131
20171

Applicants with the most clearances

Product code PFF
Applicants holding the most 510(k) clearances under product code PFF
ApplicantClearances
Illumina, Inc.1
Life Technologies Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code