Identity
- Trade Name
- Total Bilirubin Reagent Set FDA UDI
- Generic Name
- Total bilirubin IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of total bilirubin in serum. FDA UDI
- Model / Reference
- R1 x 500mL, R2 x 15mL FDA UDI
- Description
- For the quantitative determination of total bilirubin in serum. FDA UDI
Identifiers
- Catalog Number
- 501-403 FDA UDI
- Primary DI / UDI-DI
- 00812137011909 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Total bilirubin IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total bilirubin IVD, kit, enzyme spectrophotometry
Total Bilirubin Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total bilirubin IVD, kit, enzyme spectrophotometry.
- Sirrus® Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
- Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI a097a859-12cc-464f-932b-afe4f16fdcdf 36 fields · synced May 30, 2026