Creatinine plus ver.2

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Creatinine plus ver.2 FDA UDI
Generic Name: Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
Model / Reference: 08057524190 FDA UDI

Identifiers

Catalog Number: 08057524190 FDA UDI
Primary DI / UDI-DI: 07613336121160 FDA UDI
510(k) Number: K024098 FDA UDI
FDA Product Code: JFY FDA UDI
GMDN Term: Creatinine IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1225 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

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: Creatinine IVD, kit, enzyme spectrophotometry

Creatinine plus ver.2 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

K024098 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 42360225-d651-458f-ba59-fcdc10a4cb89 35 fields · synced Jun 8, 2026