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Bil

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
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 total and direct bilirubin in serum or plasma. FDA UDI
Model / Reference
BR411 FDA UDI
Description
The device is intended for the quantitative in vitro determination of total and direct bilirubin in serum or plasma. FDA UDI

Identifiers

Catalog Number
BR411 FDA UDI
Primary DI / UDI-DI
05055273200850 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

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

Yes

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, reagentTotal bilirubin IVD, reagent

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

Similar devices

Also classified as Total bilirubin IVD, reagent.

Cleared under the same submission

K973995 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI e09e6ac1-1ac4-4868-8a13-0c6dd6314645 37 fields · synced May 30, 2026