Identity
- Trade Name
- Diazyme FDA UDI
- Generic Name
- Homocysteine IVD, reagent FDA UDI
- Model / Reference
- DZ568A-K04 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089020887 FDA UDI
- GMDN Term
- Homocysteine IVD, reagent 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
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, reagent
Diazyme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, reagent.
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit — Axis-Shield Diagnostics Limited
- 3-Reagent Homocysteine Assay for SYNCHRON UniCel — Axis-Shield Diagnostics Limited · Class II
- DImension Vista® Homocysteine Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- HCY — Randox Laboratories, Ltd. · Class II
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit — Axis-Shield Diagnostics Limited · Class II
- N Latex HCY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent — Axis-Shield Diagnostics Limited · Class II
- Diazyme — Diazyme Laboratories, Inc.
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 05f84584-ae51-46ad-b2ee-ed87d9cad1f6 32 fields · synced Jun 9, 2026