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K-ASSAY® UIBC Reagent

FDA UDI

Class I (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® UIBC Reagent FDA UDI
Generic Name
Unsaturated iron binding capacity (UIBC) IVD, reagent FDA UDI
Device Name
For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. FDA UDI
Model / Reference
KAI-300 FDA UDI
Description
For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. FDA UDI

Identifiers

Catalog Number
KAI-300 FDA UDI
Primary DI / UDI-DI
00816426021396 FDA UDI
FDA Product Code
JMO FDA UDI
GMDN Term
Unsaturated iron binding capacity (UIBC) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1415 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Unsaturated iron binding capacity (UIBC) IVD, reagent

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

Similar devices

Also classified as Unsaturated iron binding capacity (UIBC) 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 ac573289-03c5-4091-8ed4-dca4f0ca45ff 36 fields · synced May 29, 2026