Identity
- Trade Name
- ENZYMATIC CHOLESTEROL FDA UDI
- Generic Name
- Total cholesterol lipid IVD, reagent FDA UDI
- Device Name
- ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH) FDA UDI
- Model / Reference
- 2145-0 FDA UDI
- Description
- ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH) FDA UDI
Identifiers
- Catalog Number
- 2145-0 FDA UDI
- Primary DI / UDI-DI
- 00852223007010 FDA UDI
- GMDN Term
- Total cholesterol lipid 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total cholesterol lipid IVD, reagent
Enzymatic Cholesterol by Sterling Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Teco Diagnostics Cholesterol TC-Matrix-480 — TECO DIAGNOSTICS · Class I
- DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
- Colesterolo Totale — GIESSE DIAGNOSTICS SRL · IVD General
- Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General
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
- Sterling Diagnostics Inc
Sources (1)
- FDA UDI f08bb7c7-6e42-481c-9bd7-42ebc8b3ad2f 34 fields · synced Jun 6, 2026