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Sekisui Diagnostics #1032

Respiratory Test Kit OSOM® Ultra Plus Influenza A + B 25 Tests CLIA Waived Sample Dependent

Name: Respiratory Test Kit
Brand: OSOM® Ultra Plus

TEST KIT, FLU A&B ULTRA PLUS (25TESTS/KT 18KT/CS)

Respiratory Test Kit OSOM® Ultra Plus Influenza A + B 25 Tests CLIA Waived Sample Dependent

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Product Specifications

McKesson #

1173369

Manufacturer #

1032

Brand

OSOM® Ultra Plus

Manufacturer

Sekisui Diagnostics

Country of Origin

United States

Application

Respiratory Test Kit

Buy American Act (BAA) Compliant

Yes

CLIA Classification

CLIA Waived for Swab Specimens

CLIA Classified

CLIA Waived Sample Dependent

Contents 1

(25) Test Sticks, (25) Sterile Nasal Swabs, (25) Extraction Buffer Vials, (1) Influenza A+ Control Swab, (1) Influenza B+ Control Swab, IFU, QRG, (1) Workstation

Is_ECAT

Is_GSA

Is_VA

Number of Tests

25 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 60 days

Purchase Program Type

Standard Purchase

Reading Type

Visual Read

Sample Type

Nasal Swab / Nasopharyngeal Swab Sample

Specialty

Immunoassay

Test Format

Dipstick Format

Test Kit Type

Rapid

Test Name

Influenza A + B

Test Type

Infectious Disease Immunoassay

Time to Results

10 Minute Results

Trade Agreement Act (TAA) Compliant

Yes

UNSPSC Code

41116144

Features

The OSOM Ultra Plus Flu A&B Test is an in vitro rapid diagnostic immunochromatography assay intended for the qualitative detection of influenza type A and B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection
Simple CLIA-waived procedure with pre-measured extraction buffer for swab samples
Accurate, differentiated interpretation of results in 10 minutes to test and treat patients in one office visit
Meets the Influenza reclassification requirements for rapid antigen tests