Liquid Crp Control - Level 2 (crp Control 2)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: LIQUID CRP CONTROL - LEVEL 2 (CRP CONTROL 2) FDA UDI
Generic Name: C-reactive protein (CRP) IVD, control FDA UDI
Device Name: This product is intended for in vitro diagnostic use in the quality control of CRP on clinical chemistry systems. FDA UDI
Model / Reference: CP2480 FDA UDI
Description: This product is intended for in vitro diagnostic use in the quality control of CRP on clinical chemistry systems. FDA UDI

Identifiers

Primary DI / UDI-DI: 05055273201703 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: C-reactive protein (CRP) IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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

Liquid Crp Control - Level 2 (crp Control 2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

ASI CRP Control Set — Arlington Scientific, Inc. · Class II
K-ASSAY® hsCRP Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
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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
ARCHITECT — Abbott Laboratories, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI b708e0b5-8b7e-4b10-9e22-db2299d1df13 35 fields · synced Jun 8, 2026