Identity
- Trade Name
- Diazyme FDA UDI
- Generic Name
- Homocysteine IVD, calibrator FDA UDI
- Model / Reference
- DZ568A-CAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089020276 FDA UDI
- GMDN Term
- Homocysteine IVD, calibrator 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Homocysteine IVD, calibrator
Diazyme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Atellica IM HCY Calibrator — Siemens Healthcare Diagnostics · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Diazyme Laboratories, Inc.
Sources (1)
- FDA UDI 2576e13a-231d-46d2-a12c-f4985c1cc6d1 32 fields · synced Jun 9, 2026