Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, control FDA UDI
- Device Name
- Beta-Hydroxybutyrate/TDM Linearity Standards FDA UDI
- Model / Reference
- CH2450604 FDA UDI
- Description
- Beta-Hydroxybutyrate/TDM Linearity Standards FDA UDI
Identifiers
- Catalog Number
- CH2450604 FDA UDI
- Primary DI / UDI-DI
- 10885380173158 FDA UDI
- FDA Product Code
- DKB FDA UDI
- GMDN Term
- Beta-hydroxybutyrate IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-hydroxybutyrate IVD, control
Cardinal Health by Cardinal Health 200, LLC — Class II — 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
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- 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
- β-Hydroxybutyrate 21 Tri-Level Controls — DiaSys Diagnostic Systems GmbH · Class I
- β-Hydroxybutyrate 21 Bi-Level Controls — DiaSys Diagnostic Systems GmbH · Class I
- Validate — LGC Clinical Diagnostics, Inc. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 3ee3881c-cf61-410a-8533-7bf450901827 35 fields · synced Jun 8, 2026