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K-ASSAY® Complement C3 Reagent

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® Complement C3 Reagent FDA UDI
Generic Name
Complement components C3/C3c IVD, reagent FDA UDI
Device Name
For the quantitative determination of human 3rd complement component (Complement C3) in serum by immunoturbidimetric assay. FDA UDI
Model / Reference
KAI-009 FDA UDI
Description
For the quantitative determination of human 3rd complement component (Complement C3) in serum by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number
KAI-009 FDA UDI
Primary DI / UDI-DI
00816426020078 FDA UDI
510(k) Number
K993437 FDA UDI
FDA Product Code
CZW FDA UDI
GMDN Term
Complement components C3/C3c IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Complement components C3/C3c IVD, reagent

K-ASSAY® Complement C3 Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Complement components C3/C3c IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kamiya Biomedical Company, Llc

Sources (1)

  • FDA UDI 2afccfb1-86ee-4773-9c6e-5b7353d31ae3 37 fields · synced May 30, 2026