Abx Pentra Enzymatic Creatinine Cp

FDA UDI

Class II (US FDA UDI)

by Horiba Abx

Identity

Trade Name: ABX PENTRA ENZYMATIC CREATININE CP FDA UDI
Generic Name: Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
Model / Reference: 1220001907 FDA UDI

Identifiers

Primary DI / UDI-DI: 03610230005637 FDA UDI
510(k) Number: K110137 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

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

Abx Pentra Enzymatic Creatinine Cp by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 4574759d-5f70-4422-a714-a95752813825 33 fields · synced Jun 6, 2026