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Audit MicroControls Linearity LQ Beta-Hydroxybutyric Acid
FDA UDIIdentity
- Trade Name
- Audit MicroControls Linearity LQ Beta-Hydroxybutyric Acid FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, control FDA UDI
- Model / Reference
- K728M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K728M50 FDA UDI
- GMDN Term
- Beta-hydroxybutyrate 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: Beta-hydroxybutyrate IVD, control
Audit MicroControls Linearity LQ Beta-Hydroxybutyric Acid by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-hydroxybutyrate IVD, control.
- TDM/B-Hydroxybutyrate Tri-Level Controls — STANBIO LABORATORY, L.P. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Diazyme — Diazyme Laboratories, Inc.
- TDM/B-Hydroxybutyrate Bi-Level Controls — STANBIO LABORATORY, L.P. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- STAT-Site B-HB Controls — STANBIO LABORATORY, L.P. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- β-Hydroxybutyrate 21 Tri-Level Controls — DiaSys Diagnostic Systems GmbH · 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 |
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Manufacturer
- Manufacturer
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI 16469aca-1d80-41bf-84e4-2d555f8a6c14 32 fields · synced May 30, 2026