NATtrol™ SARS-CoV-2 Flu/RSV Negative Control (6 x 0.5 mL) CE IVD
Catalog# NATCV9-6C-IVD
Product Information:
- Volume: 0.5mL
- Units/Pack: 6
- Storage Condition: 2-8°C
- Hazardous Information: Non-Infectious
- Matrix: Purified protein matrix treated with 0.09% sodium azide
- Product Type: Control
Description
NATtrol Flu/RSV/SARS-CoV-2 Negative 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 formulated in a proprietary purified protein matrix.
Intended Use
NATtrol Flu/RSV/SARS-CoV-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 Flu/RSV/SARS-CoV-2 Negative Control contains intact organisms 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 Flu/RSV/SARS-CoV-2 Negative Control is a USA FDA Class 1 exempt, unassayed in vitro diagnostic external run control and is for professional use only. NATtrol Flu/RSV/SARS-CoV-2 Negative Control is not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. NATtrol Flu/RSV/SARS-CoV-2 Negative 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.