Immunoassay Reagent Afinion HbA1c Test CLIA Waived For Afinion 2 Analyzer 15 Tests

The Afinion HbA1c Test is a fast and reliable immunoassay reagent designed for use with the Afinion 2 Analyzer. This test provides quantitative determination of glycated hemoglobin (HbA1c) in whole blood, helping clinicians monitor long-term glycemic control in patients with diabetes. With rapid results in just 3 minutes, this test improves patient outcomes and enhances workflow efficiency.

Key Features:

• CLIA Waived for simplified use in physician offices and clinics

• Provides quantitative HbA1c results in ~3 minutes

• Supports improved diabetic management and clinical efficiency

• Requires only 1.5 µL sample volume

• Includes 15 test cartridges per kit

• Not intended for screening use

Product Specifications:

• Manufacturer #: 1116974

• Brand: Afinion

• Manufacturer: Abbott Rapid Dx North America LLC

• Application: Immunoassay Reagent

• CLIA Classification: CLIA Waived

• For Use With: Afinion 2 Analyzer

• Number of Tests: 15

• Sample Type: Whole Blood

• Storage Requirements: Requires Refrigeration

• Test Category: Diabetes

• Test Name: HbA1c

• Test Type: Diabetes Management

• Test Format: Cartridge

• Time to Results: ~3 Minutes (HbA1c), <5 Minutes (ACR)

• UNSPSC Code: 41116104