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
Product Specifications
McKesson #
1220457
Manufacturer #
NATFRC-6C-IVD
Brand
NATtrol
Manufacturer
ZeptoMetrix Corp
Country of Origin
United States
Application
Control
Container Type
Vial
For Use With
For Evaluating Performance of Molecular Tests
Levels
Positive Level
Product Dating
McKesson Acceptable Dating: we will ship >= 30 days