Total Bilirubin 2 (t Bil 2)

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: TOTAL BILIRUBIN 2 (T BIL 2) FDA UDI
Generic Name: Total bilirubin IVD, kit, spectrophotometry FDA UDI
Device Name: For the quantitative in vitro determination of Total Bilirubin in serum and plasma. FDA UDI
Model / Reference: BR8377 FDA UDI
Description: For the quantitative in vitro determination of Total Bilirubin in serum and plasma. FDA UDI

Identifiers

Primary DI / UDI-DI: 05055273214772 FDA UDI
FDA Product Code: JFM FDA UDI
GMDN Term: Total bilirubin IVD, kit, 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total bilirubin IVD, kit, spectrophotometry

Total Bilirubin 2 (t Bil 2) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
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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 II	Pending data

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI 5da5fe31-5912-434e-9f4d-c0f9c3e6b750 35 fields · synced May 30, 2026