GBS Negative Control Microorganism (6 x 0.5 mL)

Old Part Number: MDZ054

ZeptoMetrix external controls have demonstrated performance on a variety of molecular assays. The product has been tested with the Cepheid® GeneXpert® system and provides the expected results, however performance characteristics must be established by the end user. NATtrol GBS Negative Control includes Lactobacillus acidophilus.

• Formulated with purified, intact organisms
• Organisms are chemically modified to render them noninfectious
• Refrigerator stable—store between 2 and 8°C
• Purified protein matrix treated with 0.09% sodium azide
• 6 x 0.5 mL vials
• CE IVD

NATtrol products are ready-to-use, inactivated full process controls designed to evaluate performance of molecular tests. They can be used for verification of assays, training of laboratory personnel and to monitor assay-kit lot performance. NATtrol products contain intact organisms and should be run in a manner similar to clinical specimens.

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NATtrol GBS Negative Control is a US FDA Class 1 device, 501(K) exempt, in vitro diagnostic external run control (unassayed) intended for professional use only. This product is not intended for use as a substitute for internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal, and accreditation requirements. Propagation or commercialization are prohibited without prior written consent from Antylia Scientific.

When used as a control for nucleic acid tests, the same protocols as those used to amplify extracted clinical specimens should be employed.

The suitability and performance characteristics should be determined by your laboratory for each intended usage.