HIGH SENSITIVITY CRP CONTROL - LEVEL II (hsCRP CONTROL 2)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: HIGH SENSITIVITY CRP CONTROL - LEVEL II (hsCRP CONTROL 2) FDA UDI
Generic Name: C-reactive protein (CRP) IVD, control FDA UDI
Device Name: Randox High Sensitivity CRP Control Level II is a ready to use control in a stabilised protein base. It is intended for use with the Randox High Sensitivity CRP Assay (Catalogue No. CP3885) for the control of accuracy and the control of reproducibility. FDA UDI
Model / Reference: CP2477 FDA UDI
Description: Randox High Sensitivity CRP Control Level II is a ready to use control in a stabilised protein base. It is intended for use with the Randox High Sensitivity CRP Assay (Catalogue No. CP3885) for the control of accuracy and the control of reproducibility. FDA UDI

Identifiers

Primary DI / UDI-DI: 05055273201673 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

Yes

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

HIGH SENSITIVITY CRP CONTROL - LEVEL II (hsCRP CONTROL 2) by Randox Laboratories, Ltd. — Class I — 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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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 e0beb7d9-d93f-4c7a-9ca6-cc87ea8d1b16 35 fields · synced May 30, 2026