Identity
- Trade Name
- CHOLESTEROL-SL FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 234-60 FDA UDI
Identifiers
- Catalog Number
- 234-60 FDA UDI
- Primary DI / UDI-DI
- 00628063400355 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
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: Total cholesterol lipid IVD, kit, spectrophotometry
Cholesterol-Sl by Sekisui Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, kit, spectrophotometry.
- Pointe Cholesterol Reagent — POINTE SCIENTIFIC, INC. · Class I
- STANDARD™ LipidoCare Analyzer — Sd Biosensor · Class I
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor · Class I
- Cholesterol Gen.2 — Roche Diagnostics Corp. · Class I
- 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
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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI ac98439b-55e8-49b9-8d1f-78e8f8f6d84f 33 fields · synced Jun 9, 2026