AccessGUDID - DEVICE: DIAZO-CHEK (00860009154018)

GUDID

Device Identifier (DI) Information

Brand Name: DIAZO-CHEK
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B1009
Company Name: Biorex Labs LLC

Primary DI Number: 00860009154018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060975106 *Terms of Use

Device Description: The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent strip. The Test is intended for use by the appropriately trained laboratory professionals. The test consists of Reagent discs and the test pads which bind the bilirubin from a Urine specimen. The test is based on the diazo coupling reaction between the adsorbed bilirubin and a stabilized diazonium salt of Nitrobenzene. The reaction results in the development of varying grades of purple to bluish-purple color which is easily visible by the naked eye.

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:	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?
54516	Urine bilirubin IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for bilirubin within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

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
Special Storage Condition, Specify: Refrigerate between 2-10 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 494636ec-8895-4698-81b5-6dd210a8d30d
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022