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Exact Diagnostics AMR Bundle

Respiratory Run Control
SKU:  RPRC 

Description - 2 Vials of Each:  Mix 1, Mix 2, Mix 3, Mix 4
0.3mL Fill Volume

LIMITATIONS:
For In Vitro Diagnostic Use.
​
Product Insert - within United States
Safety Data Sheet
Certificate of Analysis


Product Insert - outside United States

RESPIRATORY MIX 1
Analyte Luminex VERIGENE® Respiratory
Pathogens Flex Test
BioFire FILMARRAY®
Respiratory Panel
Roche cobas® Influenza A/B
and RSV Assay
Influenza A-H1 Detected Detected Influenza A Detected
Influenza A-H3 Detected Detected Influenza A Detected
Influenza B Detected Detected Detected
RSV A Detected RSV Detected RSV Detected
Coronavirus 229E N/A Detected N/A
RESPIRATORY MIX 2
Analyte Luminex VERIGENE® Respiratory
Pathogens Flex Test
BioFire FILMARRAY®
Respiratory Panel
Roche cobas® Influenza A/B
and RSV Assay
Rhinovirus Detected Rhinovirus/Enterovirus Detected N/A
Adenovirus Detected Detected N/A
Enterovirus N/A Rhinovirus/Enterovirus Detected N/A
Bordetella parapertussis Detected N/A N/A
RESPIRATORY MIX 3
Analyte Luminex VERIGENE® Respiratory
Pathogens Flex Test
BioFire FILMARRAY®
Respiratory Panel
Roche cobas® Influenza A/B
and RSV Assay
Parainfluenza 1 Detected Detected N/A
Parainfluenza 2 Detected Detected N/A
Parainfluenza 3 Detected Detected N/A
Parainfluenza 4 Detected Detected N/A
Coronavirus OC43 N/A Detected N/A
RESPIRATORY MIX 4
Analyte Luminex VERIGENE® Respiratory
Pathogens Flex Test
BioFire FILMARRAY®
Respiratory Panel
Roche cobas® Influenza A/B
and RSV Assay
Bordetella pertussis Detected Detected N/A
Chlamydophila pneumoniae N/A Detected N/A
Mycoplasma pneumoniae N/A Detected N/A
Influenza A H1-2009 Influenza A H1 Detected Detected Influenza A H1 Detected
RSV B Detected RSV Detected RSV Detected

INTENDED USE:
EDX Respiratory Run Controls are external quality controls, intended to be used with respiratory assays to monitor the performance of that given assay.  The control materials are whole, intact viruses and bacteria allowing operators to test the entire process of a molecular assay, train operators and test for proficiency.​

PRODUCT DESCRIPTION:
EDX Respiratory Run Controls are whole, intact viruses and bacteria that have been heat inactivated.  The control is intended to test the entire process of a variety of molecular assays including extraction, detection, and amplification.  EDX Respiratory Run Control is value assigned by digital droplet PCR. 
​
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