Identity
- Trade Name
- CHOLESTEROL (CHOL) FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the quantitative in vitro determination of Cholesterol in serum and plasma. FDA UDI
- Model / Reference
- CH200 FDA UDI
- Description
- For the quantitative in vitro determination of Cholesterol in serum and plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273201130 FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- 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
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, kit, spectrophotometry
Cholesterol (chol) by Randox Laboratories, Ltd. — FDA_510K — listed in FDA GUDID, FDA 510(k) — 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
- CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211 — Carolina Liquid Chemistries Corp. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150654 | N/A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI a6e1ff6a-8994-4d41-ad77-3b1e02c748c8 59 fields · synced Jun 18, 2026
- FDA 510(k) K150654 1 fields · synced May 29, 2026