#1211932
Siemens #11207868

Antigen Test Control Set ADVIA Centaur® SARS-CoV-2 Antigen Level 1: Negative, Level 2: Positive 4 X 1.6 mL

Name: Control Set
Brand: Advia Centaur®

CONTROL, CENTAUR SARS-COV-2 ANTIGEN QC ADVIA (4/KT) D/S

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Product Specifications

McKesson #

1211932

Manufacturer #

11207868

Brand

Advia Centaur®

Manufacturer

Siemens

Country of Origin

United States

Application

Control Set

Container Type

Vial

For Use With

For in Vitro Diagnostic use in Monitoring the Performance of the ADVIA Centaur CoV2Ag Assay using the ADVIA Centaur® Systems for the Qualitative Detection of SARS-CoV-2 Nucleocapsid Antigen

Form

Frozen Liquid

Levels

Level 1: Negative, Level 2: Positive

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Storage Requirements

Keep Frozen

Test Category

Respiratory

Test Name

SARS-CoV-2 Antigen

Test Type

Antigen Test

UNSPSC Code

41116145

Volume

4 X 1.6 mL

Features

ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
Kit contents: 2 X 1.6 mL negative quality control, level 1, 2 X 1.6 mL positive quality control, level 2 and quality control assigned value sheet
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses
Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
The ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in in vitro diagnostic procedures and proper infection control procedures
For in vitro diagnostic use
For Prescription use
For Professional use