Yumizen C1200 Total Bilirubin

FDA UDI

Class II (US FDA UDI)

by Horiba Abx

Identity

Trade Name: Yumizen C1200 Total Bilirubin FDA UDI
Generic Name: Total bilirubin IVD, kit, spectrophotometry FDA UDI
Model / Reference: 1300023835 FDA UDI

Identifiers

Primary DI / UDI-DI: 03610230006887 FDA UDI
510(k) Number: K060325 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yumizen C1200 Total Bilirubin by Horiba Abx — 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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Cleared under the same submission

K060325 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: Horiba Abx

Sources (1)

FDA UDI 011df74f-50ea-4143-8fca-436766438f21 33 fields · synced Jun 1, 2026