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K-ASSAY® Ferritin Reagent

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® Ferritin Reagent FDA UDI
Generic Name
Ferritin IVD, reagent FDA UDI
Device Name
For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay. FDA UDI
Model / Reference
KAI-095 FDA UDI
Description
For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number
KAI-095 FDA UDI
Primary DI / UDI-DI
00816426020450 FDA UDI
510(k) Number
K050944 FDA UDI
FDA Product Code
DBF FDA UDI
GMDN Term
Ferritin IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5340 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: Ferritin IVD, reagent

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

Similar devices

Also classified as Ferritin IVD, reagent.

Cleared under the same submission

K050944 also covers:

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 eb9c79d6-f9c6-4a80-bf65-0cd2f548aa81 37 fields · synced May 30, 2026