ZeptoMetrix

GBS Positive Control (6 X 0.5 mL) CE IVD (Old Part Number: MDZ053)

SKU: NATSAG-6MC-IVD

Description

NATtrol™ GBS Positive Control is formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable.Each NATtrol™ GBS Positive Control contains 6 x 0.5 mL vials of NATtrolTM Streptococcus agalactiae formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.

Intended Use

NATtrol™ Group B Streptococcus (GBS) 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 this organism. 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™ GBS 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™ GBS Positive Control is an FDA Class 1 exempt, unassayed, in vitro diagnostic external run control and is for professional use only. NATtrol™ GBS Positive Control is not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. NATtrol™ GBS 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.

Documents

Product Information

BrandZeptoMetrix
Volume6 x 0.5 mL
Units/Pack6
Unit of MeasurePK
Storage Condition2 to 8°C
Product TypeMolecular Control
StrainZ019

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