Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, kit, spectrophotometry FDA UDI
- Device Name
- Beta-Hydroxybutyrate Liquicolor FDA UDI
- Model / Reference
- CH2440058 FDA UDI
- Description
- Beta-Hydroxybutyrate Liquicolor FDA UDI
Identifiers
- Catalog Number
- CH2440058 FDA UDI
- Primary DI / UDI-DI
- 10885380173127 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Beta-hydroxybutyrate IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.25 Pound FDA UDI
Category: Beta-hydroxybutyrate IVD, kit, spectrophotometry
Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Beta-hydroxybutyrate IVD, kit, spectrophotometry.
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- β-Hydroxybutyrate 21 FS — DiaSys Diagnostic Systems GmbH · Class I
- Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® — STANBIO LABORATORY, L.P. · 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 |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 5a9e861c-9bd5-4ab3-afa7-1b584543a65e 36 fields · synced Jun 6, 2026