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Audit MicroControls Control LQ Vitamin D for Roche Systems
FDA UDIIdentity
- Trade Name
- Audit MicroControls Control LQ Vitamin D for Roche Systems FDA UDI
- Generic Name
- 25-Hydroxy vitamin D3 IVD, control FDA UDI
- Model / Reference
- K080M-6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K080M60 FDA UDI
- GMDN Term
- 25-Hydroxy vitamin D3 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: 25-Hydroxy vitamin D3 IVD, control
Audit MicroControls Control LQ Vitamin D for Roche Systems by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 25-Hydroxy vitamin D3 IVD, control.
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- Vitamin D Control — Fujirebio Diagnostics, Inc. · Class I
- PreciControl Vitamin D total II — Roche Diagnostics Corp. · Class I
- Audit MicroControls Linearity FLQ Vitamin D for Roche Systems — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FLQ Vitamin D for Ortho Vitros — Aalto Scientific, Ltd.
- Audit MicroControls Control FLQ Vitamin D — Aalto Scientific, Ltd.
- Audit MicroControls Linearity LQ Vitamin D — 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 37386602-ee52-4d1b-b40e-37c5cd7955e9 32 fields · synced May 31, 2026