AccessGUDID - DEVICE: HDL Cholesterol Reagent Set (00812137012067)

GUDID

Device Identifier (DI) Information

Brand Name: HDL Cholesterol Reagent Set
Version or Model: R1 x 2 x 70mL, R2 x 1 x 50mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501-419
Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Primary DI Number: 00812137012067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 048144997 *Terms of Use

Device Description: The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.

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?
53393	High density lipoprotein (HDL) cholesterol IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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: 7f3da08e-56a2-47b0-acd4-86913cc1afbc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 12, 2016