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 device is intended for the quantitative in vitro determination of direct bilirubin in serum or plasma. FDA UDI
Model / Reference: BR2362 FDA UDI
Description: The device is intended for the quantitative in vitro determination of direct bilirubin in serum or plasma. FDA UDI

Identifiers

Catalog Number: BR2362 FDA UDI
Primary DI / UDI-DI: 05055273200799 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

Similar devices

Also classified as Conjugated (direct) bilirubin IVD, reagent.

Alinity — Abbott · Class II
Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
Pointe Direct Bilirubin for BS480 — POINTE SCIENTIFIC, INC. · Class II
POINTE SCIENTIFIC Bilirubin, Direct — POINTE SCIENTIFIC, INC. · Class II
ClearChem Diagnostics Inc. Direct Bilirubin — CLEARCHEM DIAGNOSTICS INC. · Class II
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 57065a52-49db-446f-8cbc-9989ba010269 37 fields · synced Jun 1, 2026