FDA UDI
In Commercial Distribution
🇺🇸 United States
Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)
DI: B085K852M200
·
Model: K852M-20
·
AALTO SCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1)
- Primary DI
- B085K852M200
- Version / Model
- K852M-20
- Company Name
- AALTO SCIENTIFIC
- Labeler DUNS
- 077974989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-06
- Public Version
- 1
- Public Version Date
- 2025-01-14
- Public Version Status
- New
- Public Device Record Key
- 3ebcc209-3fea-4806-a5de-b114601d721a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65356 | Multiple traumatic brain injury marker IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen. The biochemical markers commonly include glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B085K852M200 | HIBCC |