Abx Pentra Low Crp Control

FDA UDI

Class II (US FDA UDI)

by Horiba Abx

Identity

Trade Name: ABX PENTRA LOW CRP CONTROL FDA UDI
Generic Name: C-reactive protein (CRP) IVD, control FDA UDI
Model / Reference: 1220001731 FDA UDI

Identifiers

Primary DI / UDI-DI: 03610230005477 FDA UDI
510(k) Number: K061138 FDA UDI
FDA Product Code: DCK FDA UDI
GMDN Term: C-reactive protein (CRP) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5270 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, control

Abx Pentra Low Crp Control 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, control.

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Audit MicroControls Linearity LQ hs-CRP — Aalto Scientific, Ltd.
Diazyme — Diazyme Laboratories, Inc.
POINTE SCIENTIFIC CRP Control Set — POINTE SCIENTIFIC, INC. · Class II
IMMULITE® Systems CRP CONTROL C-Reactive Protein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
DImension Vista® High Sensitivity CRP Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I

Cleared under the same submission

K061138 also covers:

ABX PENTRA IMMUNO I CONTROL L/H — 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 84767794-e862-4ed9-844b-6dc634082cd3 33 fields · synced May 30, 2026