ZeptoMetrix

Influenza A/B Positive Control (6 X 0.5 mL) CE IVD (Old Part Number: MDZ046)

SKU: NATFLUAB-6C-IVD

Description

NATtrol™ Influenza A/B Positive Control contains Influenza particles inactivated by ZeptoMetrix’s patented NATtrol™ process formulated in a proprietary 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 in in-house molecular assays and commercially available platforms.

Intended Use

The NATtrol™ Influenza A/B 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™ Influenza A/B Positive 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™ Influenza A/B Positive Control is formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each NATtrol™ Influenza A/B Positive Control contains 6 x 0.5 mL vials of NATtrolTM Influenza A and NATtrolTM Influenza B formulated in a Purified Protein Matrix.

Documents

Product Information

Brand ZeptoMetrix
Volume 6 x 0.5 mL
Units/Pack 6
Unit of Measure PK
Storage Condition 2 to 8°C
Product Type Molecular Control

Classification/Permits

IVD
CE
UKCA

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