FDA UDI
In Commercial Distribution
🇺🇸 United States
THxID™-BRAF
DI: 03573026354909
·
Model: 410697
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- THxID™-BRAF
- Primary DI
- 03573026354909
- Version / Model
- 410697
- Catalog Number
- 410697
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 7
- Public Version Date
- 2022-01-26
- Public Version Status
- Update
- Public Device Record Key
- 8b000a1f-4104-4eaf-a589-289edd1b4fa4
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58276 | BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to select treatment options and/or monitor the response to cancer therapy by determining the V600 mutation status of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene e.g., (V600A, V600D, V600E, V600K and V600R) in tumour tissue, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026354909 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120014 | 000 |
| P120014 | 001 |
| P120014 | 002 |
| P120014 | 003 |
| P120014 | 004 |
| P120014 | 005 |
| P120014 | 006 |
| P120014 | 007 |
| P120014 | 008 |
| P120014 | 009 |
| P120014 | 010 |
| P120014 | 011 |
| P120014 | 012 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius