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Picture of Reagent Kit FTD™ Molecular Diagnostic SARS-CoV-2 For use with Real-Time PCR Systems 96 Reactions 200 µL Sample Volume11416302

Reagent Kit FTD™ Molecular Diagnostic SARS-CoV-2 For use with Real-Time PCR Systems 96 Reactions 200 µL Sample Volume11416302

Reagent-Kit-FTD™-Molecular-Diagnostic-SARS-CoV-2-For-use-with-Real-Time-PCR-Systems-96-Reactions-200-µL-Sample-Volume11416302

SKU #

#1170346

MPN #

11416302

Brand

Siemens

Stock

In Stock

Quantity

100

Features

TEST KIT, FTD SARS-COV 2 96 EUA (96TST/KT) D/S

$2,059.73 USD

Attribute Name Attribute Value
McKesson # 1170346
Manufacturer # 11416302
Brand FTD™
Manufacturer Siemens
Application Reagent Kit
Container Type Vial
For Use With For use with Real-Time PCR Systems
Number of Tests 96 Reactions
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasal Swab / Nasopharyngeal Swab / Oropharyngeal Swab / Nasal Aspirate / Nasopharyngeal Wash, Aspirate Sample
Storage Requirements Keep Frozen
Test Name SARS-CoV-2
Test Type Molecular Diagnostic
UNSPSC Code 41116020
Volume 200 µL Sample Volume

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  • The use of the FTD SARS-CoV-2 as an in vitro diagnostic under the FDA Emergency Use Authorization (EUA) is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Positive results are indicative of the presence of the SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine the patient infection status
  • Positive results do not rule out bacterial infection or co- infection with other viruses
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
  • Negative results must be combined with clinical observations, patient history, and epidemiological information
  • FTD SARS-CoV-2 is intended for use by trained qualified laboratory personnel specifically instructed and trained in the techniques of RNA extractions and real-time PCR (in vitro diagnostic procedures)
  • The kit has been validated with the Applied Biosystems® 7500 Real-Time PCR System (ThermoFisher Scientific) and the NucliSENS® easyMAG® (bioMérieux)