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ZeptoMetrix

Norovirus GI/GII Positive Control (6 X 0.5 mL) CE IVD (Old Part Number: MDZ049)

SKU: NATNOV-6MC-IVD

Description

NATtrol™ Norovirus GI/GII Positive Control is formulated with purified, intact virus particles that have been chemically modified to render them non-infectious and refrigerator stable.Each NATtrol™ Norovirus GI/GII Positive Control contains 6 x 0.5 mL vials of NATtrol™ Norovirus GI/GII formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.

Intended Use

NATtrol™ Norovirus GI/GII Positive 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™ Norovirus GI/GII Positive Control contains intact virus particles and should be run in a manner identical to that used for clinical specimens. This qualitative control is not automated and 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™ Norovirus GI/GII Positive Control is a USA FDA Class 1 exempt, unassayed, in vitro diagnostic external run control and is for professional use only. NATtrol™ Norovirus GI/GII Positive Control is not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. NATtrol™ Norovirus GI/GII Positive Control is not intended for use as a primary reference standard or material for any assay or testing procedure.Quality control materials should be used in accordance with local, state, federal and accreditation requirements.

Product Information

  • BrandZeptoMetrix
  • Volume6 x 0.5 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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