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ZeptoMetrix

SARS-Related Coronavirus 2 (SARS-CoV-2) Negative Control (6 x 1.0 mL)

SKU: NATSARS(COV2)-NEG1-IVD

Description

NATtrol™ SARS-Related Coronavirus 2 Negative Control contains A-549 formulated in a proprietary purified protein matrix. These are full process controls designed to monitor the effectiveness of extraction, amplification, and detection in nucleic acid testing procedures. These controls are suitable for use with in-house molecular assays and commercially available molecular assays.

Intended Use

NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. 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™ SARS-Related Coronavirus 2 Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.

More Information

NATtrol™ SARS-Related Coronavirus 2 Negative Control is a USA FDA Class 1 exempt, unassayed in vitro diagnostic external run control and are for professional use only. NATtrol™ SARS-Related Coronavirus 2 Negative Control is not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal and accreditation requirements.

Product Information

  • BrandZeptoMetrix
  • Volume6 x 1 mL
  • Units/Pack6
  • Unit of MeasurePK
  • Storage Condition2 to 8°C
  • Product TypeMolecular Control

Classification/Permits

  • IVD

  • CE

  • UKCA

    UK Conformity Assessed (UKCA) marking is a conformity mark that indicates conformity with the applicable requirements for products sold within Great Britain, Notified Body code 0086 applied to product labeling as applicable

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