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.
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.
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.
Mucor indicus Z079, genomic crontrol DNA for LOD limit of determinantion
Mucor indicus Z079, genomic crontrol Desoxyribonucleic acid to measure LOD limit on quantification determinantion