← Back to catalogue

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
Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations) FDA UDI
Model / Reference
1.0 FDA UDI
Description
Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations) FDA UDI

Identifiers

Primary DI / UDI-DI
03573026559823 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 5ab497ae-054a-494f-82f5-7bc9dcab444b 34 fields · synced May 30, 2026