ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)

FDA UDI

Class II (US FDA UDI)

by Clearchem Diagnostics Inc.

Identity

Trade Name: ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP) FDA UDI
Generic Name: C-reactive protein (CRP) IVD, reagent FDA UDI
Device Name: In Vitro Diagnostics testing kit R1:1X20mL, R2:1X20mL FDA UDI
Model / Reference: CRP1320 FDA UDI
Description: In Vitro Diagnostics testing kit R1:1X20mL, R2:1X20mL FDA UDI

Identifiers

Catalog Number: CRP1320 FDA UDI
Primary DI / UDI-DI: 00852169008171 FDA UDI
FDA Product Code: DCK FDA UDI
GMDN Term: C-reactive protein (CRP) IVD, reagent 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

Yes

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

Dimensions & Sizes

Size: Total Volume — 40 Milliliter FDA UDI

Category: C-reactive protein (CRP) IVD, reagent

ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP) by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

CRP — Randox Laboratories, Ltd. · Class II
IMMUNEX CRP® — ALERE NORTH AMERICA, LLC · Class II
K-ASSAY® hsCRP Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
CRP Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class II
hsCRP — Randox Laboratories, Ltd. · Class II
Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
CRP — Randox Laboratories, Ltd. · Class II

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: Clearchem Diagnostics Inc.

Sources (1)

FDA UDI d939e8a6-4611-4138-86d4-a12fdb6d7684 37 fields · synced Jun 8, 2026