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Total Bilirubin LiquiColor®

FDA UDI

Class II (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
Total Bilirubin LiquiColor® FDA UDI
Generic Name
Total bilirubin IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. FDA UDI
Model / Reference
0230-450 FDA UDI
Description
The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. FDA UDI

Identifiers

Catalog Number
0230-450 FDA UDI
Primary DI / UDI-DI
00657498000588 FDA UDI
FDA Product Code
JFM 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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: Total bilirubin IVD, kit, enzyme spectrophotometry

Total Bilirubin LiquiColor® by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total bilirubin IVD, kit, enzyme spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI 2f5a51e7-c623-4bda-97d8-4eac9d1fe18c 36 fields · synced Jun 8, 2026