Identity
- Trade Name
- Diazyme FDA UDI
- Generic Name
- Fructosamine IVD, control FDA UDI
- Model / Reference
- DZ112B-LIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089022768 FDA UDI
- GMDN Term
- Fructosamine 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
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: Fructosamine IVD, control
Diazyme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fructosamine IVD, control.
- POINTE SCIENTIFIC Fructosamine Control Set — POINTE SCIENTIFIC, INC. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 — Carolina Liquid Chemistries Corp. · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Audit MicroControls Linearity DROP LQ Fructosamine for Roche Systems — Aalto Scientific, Ltd.
- FRUC CONTROL 1 — Randox Laboratories, Ltd. · Class I
- FRUC CONTROL 3 — Randox Laboratories, Ltd. · 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 48815336-fe74-4a2c-b4a1-f138263b8827 32 fields · synced Jun 9, 2026