Identity
- Trade Name
- Audit MicroControls Linearity FLQ Active B12 FDA UDI
- Generic Name
- Vitamin B12 IVD, control FDA UDI
- Model / Reference
- K980M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K980M50 FDA UDI
- GMDN Term
- Vitamin B12 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: Vitamin B12 IVD, control
Audit MicroControls Linearity FLQ Active B12 by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitamin B12 IVD, control.
- LIAISON® Vitamin B12 Control Set — Diasorin Inc.
- Atellica IM VB12 MCM — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — ABBOTT IRELAND · Class II
- Alinity — Abbott · Class I
- IMMULITE® Systems VB Calibration Verification Material Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott · Class I
- Alinity — ABBOTT IRELAND · Class I
- ADVIA Centaur® VB12 MCM — Siemens Healthcare Diagnostics · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI 8a9780dd-4e94-4853-916f-98d245e77fb3 32 fields · synced May 30, 2026