Abx Crp Std

FDA UDI

Class II (US FDA UDI)

by Horiba Abx

Identity

Trade Name: ABX CRP STD FDA UDI
Generic Name: C-reactive protein (CRP) IVD, calibrator FDA UDI
Model / Reference: 3014042432 FDA UDI

Identifiers

Primary DI / UDI-DI: 03610230004777 FDA UDI
510(k) Number: K053308 FDA UDI
FDA Product Code: JIS FDA UDI
GMDN Term: C-reactive protein (CRP) IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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: C-reactive protein (CRP) IVD, calibrator

Abx Crp Std by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as C-reactive protein (CRP) IVD, calibrator.

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CRP Ultra WR Calibrator — Sekisui Diagnostics, LLC · Class II
CRP CAL — Randox Laboratories, Ltd. · Class II
POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L) — POINTE SCIENTIFIC, INC. · Class II
CRP CAL — Randox Laboratories, Ltd. · Class II
VITROS — Ortho-Clinical Diagnostics · Class II
hsCRP CAL — Randox Laboratories, Ltd. · Class II
POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L) — POINTE SCIENTIFIC, INC. · Class II

Cleared under the same submission

K053308 also covers:

ABX CRP REA — Horiba Abx

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 3f8d1b73-af1a-4e30-adcd-2cb20e65eb49 33 fields · synced May 30, 2026