#1154497
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Abbott Rapid Dx North America LLC #1116794

HbA1c Test Kit Afinion™ HbA1c Dx HbA1c Test 15 Tests CLIA Non-Waived

Name: HbA1c Test Kit
Brand: Afinion™ HbA1c Dx

TEST KIT, HEMOGLOBIN A1C DX MOD COMPLEX (15TST/BX)

Abbott Rapid Dx North America LLC 1116794

HbA1c Test Kit Afinion™ HbA1c Dx HbA1c Test 15 Tests CLIA Non-Waived

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Product Specifications

McKesson #

1154497

Manufacturer #

1116794

Brand

Afinion™ HbA1c Dx

Manufacturer

Abbott Rapid Dx North America LLC

Country of Origin

Norway

Application

HbA1c Test Kit

CLIA Classification

CLIA Moderate Complexity

CLIA Classified

CLIA Non-Waived

Contents 1

(15) Individually Wrapped Test Cartridges with Desiccant Bag, Package Insert

For Use With

For use with Afinion™ 2 and Alere Afinion™ AS100 Analyzer

Number of Tests

15 Tests

Purchase Program Type

Standard Purchase

Reading Type

Machine Read

Sample Type

Whole Blood Sample

Specialty

Chemistry

Storage Requirements

Requires Refrigeration

Test Format

Cartridge Format

Test Kit Type

Standard

Test Name

HbA1c Test

Test Type

Diabetes Management

Time to Results

3 Minute Results

UNSPSC Code

41116104

Features

Afinion HbA1c Dx is categorized as MODERATE COMPLEXITY under the Clinical Laboratory Improvement Amendment of 1988 (CLIA’88)
Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood
The Afinion™ HbA1c Dx Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin with 3 months room temperature storage
The test cartridge should be used within 10 minutes after opening
The test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes