AccessGUDID - DEVICE: ClearChem Diagnostics Inc. Bilirubin, Direct (00852169008096)

GUDID

Device Identifier (DI) Information

Brand Name: ClearChem Diagnostics Inc. Bilirubin, Direct
Version or Model: BRD1050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRD1050
Company Name: CLEARCHEM DIAGNOSTICS INC.

Primary DI Number: 00852169008096
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 R1:3X28mL, R2:3X7mL

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?
53236	Conjugated (direct) 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 conjugated (direct) 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
Special Storage Condition, Specify: Keep Refrigerated
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 105 Milliliter

Device Record Status

Public Device Record Key: fbc9246e-a1c0-4c26-a7aa-38b07a5f1fb1
Public Version Date: May 31, 2018
Public Version Number: 1
DI Record Publish Date: April 30, 2018