AccessGUDID - DEVICE: Direct LDL Cholesterol LiquiColor® (00657498000700)

GUDID

Device Identifier (DI) Information

Brand Name: Direct LDL Cholesterol LiquiColor®
Version or Model: 0710-080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0710-080
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498000700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol in Human Serum or Plasma.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
53395	Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRR	System, Test, Low Density, Lipoprotein

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: e2daecd7-c5eb-4569-a575-9be633007003
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016