K-ASSAY® CRP (3) Reagent

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name: K-ASSAY® CRP (3) Reagent FDA UDI
Generic Name: C-reactive protein (CRP) IVD, reagent FDA UDI
Device Name: For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay. FDA UDI
Model / Reference: KAI-082 FDA UDI
Description: For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number: KAI-082 FDA UDI
Primary DI / UDI-DI: 00816426020344 FDA UDI
510(k) Number: K023828 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

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

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, reagent

K-ASSAY® CRP (3) Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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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
IMMULITE® 2000 Systems hsC High Sensitivity CRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

Cleared under the same submission

K023828 also covers:

K-ASSAY® CRP (3) Calibrator E — KAMIYA BIOMEDICAL COMPANY, LLC

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: Kamiya Biomedical Company, Llc

Sources (1)

FDA UDI a5a3fb45-261c-408a-b537-769dced364e6 37 fields · synced May 30, 2026