Bilirubin Total Gen.3

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Bilirubin Total Gen.3 FDA UDI
Generic Name: Total bilirubin IVD, kit, spectrophotometry FDA UDI
Model / Reference: 10421428190 FDA UDI

Identifiers

Catalog Number: 10421428190 FDA UDI
Primary DI / UDI-DI: 07613336235515 FDA UDI
510(k) Number: K131544 FDA UDI
FDA Product Code: CIG 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: Total bilirubin IVD, kit, spectrophotometry

Bilirubin Total Gen.3 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K131544 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: Roche Diagnostics Corp.

Sources (1)

FDA UDI 119ee79c-c7af-4182-ab8f-f2e34959a72c 34 fields · synced Jun 6, 2026