Identity
- Trade Name
- LDL Cholesterol Reagent Set FDA UDI
- Generic Name
- Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry FDA UDI
- Device Name
- The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy. FDA UDI
- Model / Reference
- R1 x 2 x 70mL, R2 x 1 x 50mL FDA UDI
- Description
- The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy. FDA UDI
Identifiers
- Catalog Number
- 501-420 FDA UDI
- Primary DI / UDI-DI
- 00812137012074 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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
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
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: Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry
LDL Cholesterol Reagent Set by Clinical Diagnostic Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI e589da2e-e125-48e0-add2-f8e08c9d7678 36 fields · synced May 30, 2026