AccessGUDID - DEVICE: LDL Cholesterol Reagent Set (00812137012074)

GUDID

Device Identifier (DI) Information

Brand Name: LDL Cholesterol Reagent Set
Version or Model: R1 x 2 x 70mL, R2 x 1 x 50mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501-420
Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Primary DI Number: 00812137012074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 048144997 *Terms of Use

Device 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.

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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53409	Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of dense low density lipoprotein (DLDL) cholesterol lipid in a clinical specimen, using a mass spectrometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBR	Ldl & Vldl Precipitation, Hdl

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: e589da2e-e125-48e0-add2-f8e08c9d7678
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 12, 2016