AccessGUDID - DEVICE: Multi-Analyte Lipid Control Set (00812137012197)

GUDID

Device Identifier (DI) Information

Brand Name: Multi-Analyte Lipid Control Set
Version or Model: L1 x 3mL, L2 x 3mL, L3 x 3mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 502-160
Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Primary DI Number: 00812137012197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 048144997 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44695	High density lipoprotein (HDL) cholesterol IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d14530a9-ca5f-4851-931c-ef53c4160255
Public Version Date: March 08, 2022
Public Version Number: 3
DI Record Publish Date: October 12, 2016