Alere Afinion™ ACR

FDA UDI

Class II (US FDA UDI)

by Abbott Diagnostics Technologies AS

Identity

Trade Name: Alere Afinion™ ACR FDA UDI
Generic Name: Microalbumin IVD, reagent FDA UDI
Device Name: Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumin, creatinine and the albumin/creatinine ratio in human urine. Contents: 15 Test Cartridges. 1 Package insert. DI covers Alere Afinion ACR and Afinion ACR. FDA UDI
Model / Reference: 1115020 FDA UDI
Description: Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumin, creatinine and the albumin/creatinine ratio in human urine. Contents: 15 Test Cartridges. 1 Package insert. DI covers Alere Afinion ACR and Afinion ACR. FDA UDI

Identifiers

Catalog Number: 1115020 FDA UDI
Primary DI / UDI-DI: 07070060005744 FDA UDI
FDA Product Code: JFY FDA UDI
JIR FDA UDI
GMDN Term: Microalbumin IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1225 FDA UDI
862.1645 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Category: Microalbumin IVD, reagent

Alere Afinion™ ACR by Abbott Diagnostics Technologies AS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microalbumin IVD, reagent.

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

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: Abbott Diagnostics Technologies AS

Sources (1)

FDA UDI 1b56c76d-d77c-43ec-8ed8-6af36b9273c5 36 fields · synced Jun 8, 2026