FDA.reportPublic FDA data

DIAZO-CHEK

Primary DI
00860009154018
Brand
DIAZO-CHEK
Company
Biorex Labs LLC
Model
1
Catalog number
B1009
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.
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009154018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009154018008600091540188600091540180860009154018

GMDN Terms#

Term, Definition table
TermDefinition
Urine bilirubin IVD, kit, rapid colorimetric, clinicalA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Refrigerate between 2-10 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-824-3000info@biorexlabs.com

Regulatory Flags#

DUNS number
060975106
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009154001K-CHECK1B15552022-12-02
00860009154025K-CHECK CONTROLS1B17772022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JJB2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JJB2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JJB2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JJB2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JJB2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JJB2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JJB2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JJB2025-09-18
00850054026729QMedix™Diagnostic Automation, Inc.JJB2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JJB2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJJB2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJJB2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJJB2024-06-04
08806141303497One+Step 10ADFI CO.,LTDJJB2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JJB2023-06-08
10884389181973MedlineMEDLINE INDUSTRIES, INC.JJB2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JJB2021-09-16
00722066005255Rapid ResponseBTNX IncJJB2020-12-14
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JJB2020-09-30