Identity
- Trade Name
- β-Hydroxybutyrate 21 Bi-Level Controls FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, control FDA UDI
- Device Name
- For use as controls in quantative procedures for β-Hydroxybutyrate FDA UDI
- Model / Reference
- 595409943084 FDA UDI
- Description
- For use as controls in quantative procedures for β-Hydroxybutyrate FDA UDI
Identifiers
- Catalog Number
- 595409943084 FDA UDI
- Primary DI / UDI-DI
- 04051839002921 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Beta-hydroxybutyrate IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- 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
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
β-Hydroxybutyrate 21 Bi-Level Controls by DiaSys Diagnostic Systems GmbH — Class I — 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
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DiaSys Diagnostic Systems GmbH
Sources (1)
- FDA UDI b6ace5fa-9e0d-4126-b955-cbb9203ac214 35 fields · synced May 30, 2026