K-ASSAY® Apo AI Reagent

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref KAI-002

by Kamiya Biomedical Company, Llc

Identity

Trade Name: K-ASSAY® Apo AI Reagent FDA UDI
Generic Name: Apolipoprotein A-I (Apo A1) IVD, reagent FDA UDI
Device Name: Apo AI Reagent EUDAMED
For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay. FDA UDI
Model / Reference: KAI-002 EUDAMEDFDA UDI
Description: For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number: KAI-002 FDA UDI
Primary DI / UDI-DI: 00816426020016 EUDAMEDFDA UDI
Basic UDI-DI: B-00816426020016 EUDAMED
510(k) Number: K993345 FDA UDI
FDA Product Code: DER FDA UDI
EMDN Code: W0102010401 APOLIPOPROTEIN A I EUDAMED
GMDN Term: Apolipoprotein A-I (Apo A1) IVD, reagent FDA UDI

Classification

Device Class: Class IVD General EUDAMED
Class II FDA UDI
Regulation Number: 866.5580 FDA UDI
Market of Registration: Czechia EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

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: Apolipoprotein A-I (Apo A1) IVD, reagent

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

Similar devices

Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.

APOLIPOPROTEÍNA A1 — QUIMICA CLINICA APLICADA S.A. · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Nephstar Apo A1 Kit — Goldsite Diagnostics Inc. · IVD General
APO A1 — Medicon Hellas SA · IVD General
Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
Apolipoprotein A1 — Diagam S.A. · IVD General
Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kamiya Biomedical Company, Llc

Sources (2)

FDA UDI bb78505c-d068-4e39-b7a9-9af4a9770b70 37 fields · synced Jul 11, 2026
EUDAMED 613aae44-9dca-4965-b4a7-c646821f0fa0 61 fields · synced Jul 11, 2026