Identity
- Trade Name
- TDM/B-Hydroxybutyrate Bi-Level Controls FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, control FDA UDI
- Device Name
- For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate. FDA UDI
- Model / Reference
- 2465-605 FDA UDI
- Description
- For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate. FDA UDI
Identifiers
- Catalog Number
- 2465-605 FDA UDI
- Primary DI / UDI-DI
- 00657498000540 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Beta-hydroxybutyrate IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
TDM/B-Hydroxybutyrate Bi-Level Controls by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI f0362d7a-0287-47de-8ae7-6173bbfdb64c 36 fields · synced May 30, 2026