DIAZO-CHEK B1009

GUDID 00860009154018

Urine bilirubin IVD, kit, rapid colorimetric, clinical

Primary Device ID	00860009154018
NIH Device Record Key	494636ec-8895-4698-81b5-6dd210a8d30d
Commercial Distribution Status	In Commercial Distribution
Brand Name	DIAZO-CHEK
Version Model Number	1
Catalog Number	B1009
Company DUNS	060975106
Company Name	Biorex Labs LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius

Device Issuing Agency	Device ID
GS1	00860009154018 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	false

00860009154001 - K-CHECK	2022-12-12 The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-qu
00860009154018 - DIAZO-CHEK	2022-12-12The 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.
00860009154018 - DIAZO-CHEK	2022-12-12 The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent str
00860009154025 - K-CHECK CONTROLS	2022-12-12 The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy an