Neisseria gonorrhoeae Z017, titered control for LOD limit of detection determination in diagnostic kits
Caution when handling viruses
Viral antigens, culture fluids, DNA controls and samples should only be opened in a BL2 protected laboratory. Infectious viruses are Biologic Safety level 2 organisms. Viral culture fluids are tested for their Tissue Culture Infective Dose or TCID50. we recommend to use titers higher than10*5 U/ml. LOD or limit of detection determinations , IVD Assay development, molecular diagnostics and other viral based IVD assays can be developed with viral antigens, DNAs and fluid viral samples.
Intended IVD use
Only for research use in virology laboratories with biosafety level 2 rooms. For IVD an ISO 13485 CE certification is needed. Do not use these virus related reagents for production of products witch are mentioned in section 351 of the Public Health Service Act.
Isotype or positive controls by peptides, antibodies and deactivated samples. The detections of the targets with this kit is a type of test that can be performed on any target containing biological samples after clean up of interfering agents. The assay must be performed following the protocol. CE marked for diagnostic use in ISO 13485 certified in Vitro Diagnostic devices IVVD. Available in 1 for diagnostics.
Neisseria gonorrhoeae Z017, titered control for LOD limit of determination in
Neisseria gonorrhoeae Z017, titered reference to measure LOD limit on quantification measurement in diagnostic reagens
Scope note:An in vitro allergen radioimmunoassay in which allergens are coupled to an immunosorbent. The coupled allergens bind the IgE in the sera of patients which in turn binds radioisotope-labeled anti-IMMUNOGLOBULIN E antibodies.
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