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Polaris® Taq Polymerase 50 U/µL, IVD

Storage Conditions:
-85 °C to -15 °C

Validated Class A IVD reagent optimized for diverse diagnostics across various biological matrices and conditions. Its high-concentration enzyme format and lyophilization compatibility enable flexible, robust, and sensitive assay customization. For smaller-scale (200 reactions), view the Polaris® qPCR Flexible Pack.

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Polaris® Taq Polymerase 50 U/µL, IVD, designed for in vitro diagnostic (IVD) applications, is an optimized and highly robust diagnostic tool, meticulously designed to meet the high demands of modern medical diagnostics. The formulation boasts a high concentration of 50 U/µL, designed to facilitate the concentrated bulk production of PCR master mixes. Despite containing 50% glycerol to enhance stability and protect against freezing conditions, its high concentration ensures minimal glycerol incorporation into master mixes, thus maintaining compatibility with lyophilization processes. The result is a highly versatile enzyme that retains the reproducible performance expected in diagnostic applications, even when used in lower volumes. Accommodating a broad spectrum of PCR requirements, Polaris® Taq Polymerase 50 U/µL, IVD, is especially suited for challenging and multiplex PCR applications that demand rapid amplification without compromising specificity or sensitivity.

Polaris® Taq Polymerase 50 U/µL, IVD, is produced under a rigorous quality management system according to global standards for medical devices and IVD manufacturing, including stringent quality assurance, full traceability from production, and reliability in its diagnostic applications. The efficacy of Polaris® Taq Polymerase 50 U/µL, IVD, is especially relevant in the field of molecular diagnostics, as evidenced in this instructions for use through extensive validation for detecting a wide range of viral and bacterial pathogens, including SARS-CoV-2, Respiratory Syncytial Virus (RSV, subtypes A and B), Influenza (types A and B), methicillin-resistant Staphylococcus aureus (MRSA), and 14 high-risk types of Human Papillomavirus (HPV) in human clinical specimens. The comprehensive validation of Polaris® Taq Polymerase 50 U/µL, IVD, across diverse clinical matrices, establishes it as a validated Class A IVD reagent for molecular diagnostics.
  • Sensitivity and Specificity
  • Accuracy and Reproducibility
  • Stability and Robustness


Intended Use:
Polaris® Taq Polymerase 50 U/µL, IVD, is a validated Class A IVD reagent, intended for professional use in the real-time PCR detection of viral, bacterial and fungal nucleic acids in swab samples collected from patients. A positive result indicates the presence of pathogen nucleic acids but a clinical correlation with patient history and other diagnostic information is necessary to determine the patient's infection status. Negative results do not preclude microbial infection and should not be used as the sole basis for patient management decisions. Thus, the results obtained with this enzyme should be interpreted in conjunction with other clinical and laboratory findings. This IVD reagent is intended for use by properly licensed laboratory professionals. The performance characteristics of this product were established based on the detection of the respiratory viruses SARS-CoV-2, Influenza types A and B, and RSV, and other two highly relevant human pathogens, MRSA and HPV. Laboratories should validate performance for other targets according to local regulations and guidelines.

The extensive validation and versatility of this enzyme underscores Polaris® Taq Polymerase 50 U/µL, IVD, as a robust class A diagnostic reagent, capable of accommodating varied diagnostic demands and capable of delivering reliable results across different biological matrices and testing conditions.

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More Information
Shipping Conditions Room Temperature
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Fast, Multiplex, Thermostable
Taq 50 U/µL
More Information
Shipping Conditions Room Temperature
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Fast, Multiplex, Thermostable
More Information
Shipping Conditions Room Temperature
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Fast, Multiplex, Thermostable

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