Identity
- Trade Name
- Cholesterol Gen.2 FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 04718917190 FDA UDI
Identifiers
- Catalog Number
- 04718917190 FDA UDI
- Primary DI / UDI-DI
- 04015630922062 FDA UDI
- 510(k) Number
- K031824 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Total cholesterol lipid IVD, kit, spectrophotometry
Cholesterol Gen.2 by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total cholesterol lipid IVD, kit, spectrophotometry.
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- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- POINTE SCIENTIFIC Cholesterol (Liquid) — POINTE SCIENTIFIC, INC. · Class I
- CHOLESTEROL (CHOL) — Randox Laboratories, Ltd. · Class I
- CHOLESTEROL (CHOL) — Randox Laboratories, Ltd. · Class I
Cleared under the same submission
K031824 also covers:
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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 242b35ed-aef2-4085-8369-70bb431bf984 34 fields · synced Jun 8, 2026