Identity
- Trade Name
- DIAZO-CHEK FDA UDI
- Generic Name
- Urine bilirubin IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- B1009 FDA UDI
- Primary DI / UDI-DI
- 00860009154018 FDA UDI
- FDA Product Code
- JJB FDA UDI
- GMDN Term
- Urine bilirubin IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1115 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine bilirubin IVD, kit, rapid colorimetric, clinical
Diazo-Chek by Biorex Labs LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biorex Labs LLC
Sources (1)
- FDA UDI 494636ec-8895-4698-81b5-6dd210a8d30d 36 fields · synced Jun 1, 2026