Identity
- Trade Name
- Diazyme FDA UDI
- Generic Name
- Beta-hydroxybutyrate IVD, control FDA UDI
- Model / Reference
- DZ153A-CON FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089023154 FDA UDI
- GMDN Term
- Beta-hydroxybutyrate IVD, control FDA UDI
Classification
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-hydroxybutyrate IVD, control
Diazyme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Beta-hydroxybutyrate IVD, control.
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
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- β-Hydroxybutyrate 21 Bi-Level Controls — DiaSys Diagnostic Systems GmbH · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Diazyme Laboratories, Inc.
Sources (1)
- FDA UDI 8cc5b31f-2916-4716-a35d-1ff9040cb9d1 32 fields · synced Jun 9, 2026