D Bil

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: D BIL FDA UDI
Generic Name: Conjugated (direct) bilirubin IVD, reagent FDA UDI
Device Name: The DBIL method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of direct (conjugated) bilirubin in serum or plasma. FDA UDI
Model / Reference: BR2801 FDA UDI
Description: The DBIL method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of direct (conjugated) bilirubin in serum or plasma. FDA UDI

Identifiers

Catalog Number: BR2801 FDA UDI
Primary DI / UDI-DI: 05055273200812 FDA UDI
510(k) Number: K973995 FDA UDI
FDA Product Code: GIG FDA UDI
GMDN Term: Conjugated (direct) bilirubin IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7500 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Conjugated (direct) bilirubin IVD, reagent

D Bil by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ARCHITECT — Abbott · Class II
Teco Diagnostics Direct Bilirubin TC-Matrix — TECO DIAGNOSTICS · Class II
IDG/Sanzay — IDG/SANZAY Corporation · Class II

Cleared under the same submission

K973995 also covers:

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 1223cbab-06bf-46d6-b71a-e0a03af610b2 37 fields · synced Jun 1, 2026