FDA UDI
In Commercial Distribution
🇺🇸 United States
VIDAS® TBI (GFAP, UCH-L1)
DI: 03573026626891
·
Model: VIDAS® TBI (GFAP, UCH-L1)
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VIDAS® TBI (GFAP, UCH-L1)
- Primary DI
- 03573026626891
- Version / Model
- VIDAS® TBI (GFAP, UCH-L1)
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-31
- Public Version
- 1
- Public Version Date
- 2024-11-08
- Public Version Status
- New
- Public Device Record Key
- cf635e1d-56d4-4944-b1d6-a1b6f591863e
Device Description
VIDAS TBI (GFAP, UCH-L1) is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the evaluation of mTBI patients to assist in determining the need for a CT scan
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 |
|---|---|---|---|---|
| QAT | Brain trauma assessment test | Immunology | 866.5830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66871 | Multiple traumatic brain injury marker IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen, using a fluorescent immunoassay method. This test is used to detect glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) as an aid to determine the need for a neuroimaging radiological scan following head injury. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026626891 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240279 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius