Identity
- Trade Name
- Diayzme FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
- Model / Reference
- DZ129A-KY1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089021006 FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol 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: High density lipoprotein (HDL) cholesterol IVD, reagent
Diayzme by Diazyme Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, reagent.
- Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix — TECO DIAGNOSTICS · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- Pointe Scientific — POINTE SCIENTIFIC, INC. · Class I
- ACE — Alfa Wassermann, Inc. · Class I
- PTS Panels® HDL Cholesterol Test Strips — Polymer Technology Systems · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- Teco Diagnostics HDL Cholesterol Reagent Set — TECO DIAGNOSTICS · Class I
- Teco Diagnostics HDL Cholesterol Reagent Set — TECO DIAGNOSTICS · 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 1d5fc47f-8034-4086-b426-8741435ce043 32 fields · synced Jun 9, 2026