DIAZO-CHEK B1009

GUDID 00860009154018

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.

Biorex Labs LLC

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Primary Device ID00860009154018
NIH Device Record Key494636ec-8895-4698-81b5-6dd210a8d30d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIAZO-CHEK
Version Model Number1
Catalog NumberB1009
Company DUNS060975106
Company NameBiorex Labs LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009154018 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-02

Devices Manufactured by Biorex Labs LLC

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00860009154018 - DIAZO-CHEK2022-12-12The 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-CHEK2022-12-12 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 CONTROLS2022-12-12 The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy an
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