Identity
- Trade Name
- β-Hydroxybutyrate 21 Linearity Standards FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, calibrator FDA UDI
- Device Name
- For use as linearity standards in quantitative procedures for β-Hydroxybutyrate FDA UDI
- Model / Reference
- 137209943052 FDA UDI
- Description
- For use as linearity standards in quantitative procedures for β-Hydroxybutyrate FDA UDI
Identifiers
- Catalog Number
- 137209943052 FDA UDI
- Primary DI / UDI-DI
- 04051839002938 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Beta-hydroxybutyrate IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
β-Hydroxybutyrate 21 Linearity Standards by DiaSys Diagnostic Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-hydroxybutyrate IVD, calibrator.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- STAT-Site Linearity Check — STANBIO LABORATORY, L.P. · Class I
- TDM/B-Hydroxybutyrate Linearity Standards — STANBIO LABORATORY, L.P. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- DiaSys Diagnostic Systems GmbH
Sources (1)
- FDA UDI 3146d0a0-b023-4054-b743-ebc5961197b4 35 fields · synced May 30, 2026