AccessGUDID - DEVICE: ClearChem Diagnostics Inc. Total Bilirubin (00852169008317)

GUDID

Device Identifier (DI) Information

Brand Name: ClearChem Diagnostics Inc. Total Bilirubin
Version or Model: BRB212
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CLEARCHEM DIAGNOSTICS INC.

Primary DI Number: 00852169008317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010655581 *Terms of Use

Device Description: In Vitro Diagnostics testing kit R1C: 4X52.5mL, R1B: 4X52.5mL

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):	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?
53231	Total bilirubin 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 total bilirubin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIG	Diazo Colorimetry, Bilirubin

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
Total Volume: 420 Milliliter

Device Record Status

Public Device Record Key: 8b2bef5e-d0fc-4514-abd6-5440ab92cb3e
Public Version Date: January 30, 2023
Public Version Number: 1
DI Record Publish Date: January 20, 2023