K-ASSAY® Microalbumin Reagent

FDA UDI

Class II (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name: K-ASSAY® Microalbumin Reagent FDA UDI
Generic Name: Microalbumin IVD, reagent FDA UDI
Device Name: For the quantitative determination of human albumin in urine by immunoturbidimetric assay. FDA UDI
Model / Reference: KAI-019 FDA UDI
Description: For the quantitative determination of human albumin in urine by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number: KAI-019 FDA UDI
Primary DI / UDI-DI: 00816426020139 FDA UDI
510(k) Number: K091486 FDA UDI
FDA Product Code: DCF FDA UDI
GMDN Term: Microalbumin IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5040 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: Microalbumin IVD, reagent

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

Similar devices

Also classified as Microalbumin IVD, reagent.

Alere Afinion™ ACR — Abbott Diagnostics Technologies AS · Class II
Afinion ACR — Abbott Diagnostics Technologies AS · Class II
ClearChem Diagnostics Inc. MicroAlbumin — CLEARCHEM DIAGNOSTICS INC. · Class II
Pointe Scientific, Inc. Microalbumin — POINTE SCIENTIFIC, INC. · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II
K-ASSAY® Microalbumin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLC · Class II

Cleared under the same submission

K091486 also covers:

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 16b01e1e-d685-44a6-8229-2cf18537b85e 37 fields · synced May 29, 2026