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Abbott Rapid Dx North America LLC #7D2648

Sexual Health Test Kit Determine™ HIV-1/2 Ag/Ab Combo 25 Tests CLIA Waived Sample Dependent

Name: Sexual Health Test Kit
Brand: Determine™

TEST, DETERMINE HIV-1/2 AG/ABWAIVED (25/KT)

Abbott Rapid Dx North America LLC 7D2648

Sexual Health Test Kit Determine™ HIV-1/2 Ag/Ab Combo 25 Tests CLIA Waived Sample Dependent

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Product Specifications

McKesson #

875804

Manufacturer #

7D2648

Brand

Determine™

Manufacturer

Abbott Rapid Dx North America LLC

Country of Origin

United States

Application

Sexual Health Test Kit

CLIA Classification

CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum, Plasma

CLIA Classified

CLIA Waived Sample Dependent

Contents 1

(25) Test Cards, Chase Buffer, Package Insert, Quick Reference Guide, (25) Capillary Tubes, (25) Disposable Workstations

Number of Tests

25 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Purchase Program Type

Standard Purchase

Reading Type

Visual Read

Sample Type

Whole Blood / Serum / Plasma Sample

Specialty

Immunoassay

Technology

Lateral Flow

Test Format

Test Card Format

Test Kit Type

Rapid

Test Method

Lateral Flow Method

Test Name

HIV-1/2 Ag/Ab Combo

Test Type

Antibody / Antigen Test

Time to Results

20 Minute Results

UNSPSC Code

41116144

Features

Innovative: The first and only FDA cleared point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen on single test strip
CLIA Waived (Fingerstick Collection): 3 easy steps and minimal training to allow testing across a range of test sites
Proven: 99.9% overall clinical sensitivity for all sample types
Rapid: Results in just 20 minutes
Flexible Sample Types: Test using capillary and venous whole blood, serum, and plasma
Each test strip has a cover that is to be removed for sample application and visualization of test results