Identity
- Trade Name
- Direct Bilirubin LiquiColor® FDA UDI
- Generic Name
- Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the quantitative colorimetric determination of Direct Bilirubin in Serum and Plasma. FDA UDI
- Model / Reference
- 0235-450 FDA UDI
- Description
- For the quantitative colorimetric determination of Direct Bilirubin in Serum and Plasma. FDA UDI
Identifiers
- Catalog Number
- 0235-450 FDA UDI
- Primary DI / UDI-DI
- 00657498000564 FDA UDI
- FDA Product Code
- JFM FDA UDI
- GMDN Term
- Conjugated (direct) 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
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: Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry
Direct Bilirubin LiquiColor® by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry.
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- Sirrus® Direct 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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI f75d27a5-d102-4d66-bb89-50fa660672a6 36 fields · synced Jun 1, 2026