THxID™-BRAF 410697
GUDID 03573026354909
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
BIOMERIEUX SA
BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 03573026354909 |
| NIH Device Record Key | 8b000a1f-4104-4eaf-a589-289edd1b4fa4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THxID™-BRAF |
| Version Model Number | 410697 |
| Catalog Number | 410697 |
| Company DUNS | 276816717 |
| Company Name | BIOMERIEUX SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026354909 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P120014
FDA Product Code
| OWD | Somatic Gene Mutation Detection System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2022-01-26 |
| Device Publish Date | 2014-09-23 |
Devices Manufactured by BIOMERIEUX SA
| 03573026216801 - CHROMID® P. aeruginosa Agar | 2026-01-21 Direct identification of Pseudomonas aeruginosa in pulmonary specimens. |
| 03573026118952 - CHROMID® Candida Agar | 2026-01-21 Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans |
| 03573026316969 - CHROMID® C. difficile | 2026-01-21 Chromogenic medium for the detection and ident ification of Clostridium difficile. |
| 03573026374846 - CHROMID® Salmonella Elite | 2026-01-19 chromID™ Salmonella Eliteagar is a chromogenic medium for the selective isolation and identification of Salmonellain human spe |
| 03573026443900 - CHROMID® CPS® Elite Agar (CPSE) | 2026-01-19 Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms |
| 03573026468170 - CHROMID® CPS® Elite Agar (CPSO) | 2026-01-19 Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms |
| 03573026468545 - CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood | 2026-01-19 This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for u |
| 03573026631994 - ETEST® Aztreonam Avibactam (AZA) | 2025-10-03 ETEST is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
Trademark Results [THxID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THXID 79121917 4366559 Live/Registered |
bioMérieux 2012-10-10 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.