Duns Number:276816717
Device Description: The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue
Catalog Number
410697
Brand Name
THxID™-BRAF
Version/Model Number
410697
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P120014,P120014,P120014,P120014,P120014,P120014,P120014,P120014,P120014,P120014,P120014,P120014,P120014
Product Code
OWD
Product Code Name
Somatic Gene Mutation Detection System
Public Device Record Key
8b000a1f-4104-4eaf-a589-289edd1b4fa4
Public Version Date
January 26, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |