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THxID™-BRAF

FDA UDI

Class III (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
THxID™-BRAF FDA UDI
Generic Name
BRAF gene mutation IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
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 FDA UDI
Model / Reference
410697 FDA UDI
Description
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 FDA UDI

Identifiers

Catalog Number
410697 FDA UDI
Primary DI / UDI-DI
03573026354909 FDA UDI
PMA Number
P120014 FDA UDI
FDA Product Code
OWD FDA UDI
GMDN Term
BRAF gene mutation IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: BRAF gene mutation IVD, kit, nucleic acid technique (NAT)

THxID™-BRAF by Biomerieux , Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as BRAF gene mutation IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

P120014 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 8b000a1f-4104-4eaf-a589-289edd1b4fa4 36 fields · synced Jun 1, 2026