510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OWDClass III

Somatic Gene Mutation Detection System

Unknown
FDA source (opens on fda.gov)

OWD is the FDA product code for Somatic Gene Mutation Detection System, a class III device type. FDA's definition for this code reads: "The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues". As of , FDA records hold no 510(k) clearances under this code and 13 recalls.

Classification record

Product code
OWD
Device name
Somatic Gene Mutation Detection System
FDA definition
The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
13

Companies listing this code with FDA

Companies whose registered establishments list this code