Identity
- Trade Name
- Diazyme FDA UDI
- Generic Name
- Multiple lipid analyte IVD, control FDA UDI
- Model / Reference
- DZ138A-CON FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089020023 FDA UDI
- GMDN Term
- Multiple lipid analyte 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
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: Multiple lipid analyte IVD, control
Diazyme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) — Randox Laboratories, Ltd. · Class I
- LIQUID QC LIPID CONTROL LEVEL 2 — CLINIQA CORPORATION · Class I
- LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1) — Randox Laboratories, Ltd. · Class I
- Pointe Scientfic, Inc. Lipid Controls — POINTE SCIENTIFIC, INC. · 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 eb0ef562-d455-4dfe-9ae6-52e58eca5abe 32 fields · synced Jun 9, 2026