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Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH
FDA UDIIdentity
- Trade Name
- Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH FDA UDI
- Generic Name
- Multiple traumatic brain injury marker IVD, control FDA UDI
- Device Name
- Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)". FDA UDI
- Model / Reference
- K089M-8 FDA UDI
- Description
- Note - Max characters were exceeded for Brand Name field. Brand name is "Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH-L1)". FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K089M80 FDA UDI
- GMDN Term
- Multiple traumatic brain injury marker IVD, control FDA UDI
Classification
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple traumatic brain injury marker IVD, control
Audit MicroControls Control FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, UCH by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID
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Also classified as Multiple traumatic brain injury marker IVD, control.
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- Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1) — Aalto Scientific, Ltd.
- Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP) — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD Traumatic Brain Injury (TBI) — Aalto Scientific, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI bb27d505-09d8-4002-9822-d282e500b918 33 fields · synced May 30, 2026