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Multi-Analyte Lipid Control Set

FDA UDI

Class I (US FDA UDI)

by Clinical Diagnostic Solutions, Inc.

Identity

Trade Name
Multi-Analyte Lipid Control Set FDA UDI
Generic Name
High density lipoprotein (HDL) cholesterol IVD, control FDA UDI
Device Name
This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum. FDA UDI
Model / Reference
L1 x 3mL, L2 x 3mL, L3 x 3mL FDA UDI
Description
This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum. FDA UDI

Identifiers

Catalog Number
502-160 FDA UDI
Primary DI / UDI-DI
00812137012197 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
High density lipoprotein (HDL) cholesterol IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Yes

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: High density lipoprotein (HDL) cholesterol IVD, control

Multi-Analyte Lipid Control Set by Clinical Diagnostic Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as High density lipoprotein (HDL) cholesterol IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinical Diagnostic Solutions, Inc.

Sources (1)

  • FDA UDI d14530a9-ca5f-4851-931c-ef53c4160255 36 fields · synced Jun 8, 2026