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  • #1220457
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  • ZeptoMetrix Corp #NATFRC-6C-IVD

Control NATtrol™ Flu / RSV / SARS-CoV-2 Positive Level 6 X 0.5 mL

CONTROL, NATTROL FLU/RSV/SARS-COV-2 POS 6X0.5ML

Features

  • NATtrol SARS-CoV-2 Flu/RSV Positive Control is a US FDA Class 1 device, 501(K) exempt, in vitro diagnostic external run control (unassayed) intended for professional use only
  • The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state
  • The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors
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Product Specifications


Features
  • NATtrol SARS-CoV-2 Flu/RSV Positive Control is a US FDA Class 1 device, 501(K) exempt, in vitro diagnostic external run control (unassayed) intended for professional use only
  • The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state
  • The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors
  • NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens
  • NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control is formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable
  • Each control pack contains 6 x 0.5 mL vials of NATtrol™ inactivated virus listed in Table 1 formulated in a proprietary purified protein matrix
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