AccessGUDID - DEVICE: Cholesterol Gen.2 (04015630924967)

GUDID

Device Identifier (DI) Information

Brand Name: Cholesterol Gen.2
Version or Model: 05168538190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05168538190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630924967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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?
53359	Total cholesterol lipid IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031824	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e5bb7b45-16a2-4e32-8abc-8596d06ad6ae
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: February 08, 2021