NATrol molecular control control Panel for IVD for Human Parvovirus B19 10,000,000 IU/mL
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.
Human proteins, cDNA and human recombinants are used in human reactive ELISA kits and to produce anti-human mono and polyclonal antibodies. Modern humans (Homo sapiens, primarily ssp. Homo sapiens sapiens). Depending on the epitopes used human ELISA kits can be cross reactive to many other species. Mainly analyzed are human serum, plasma, urine, saliva, human cell culture supernatants and biological samples.
NATrol molecular control control Panel for IVD for Parvovirus B19 10,000,000 IU/
NATrol molecular reference control Panel to measure IVD to measure H. sapiens Parvovirus B19 10,000,000 IU/milliliter
Scope note:Recording of pertinent information concerning patient's illness or illnesses.
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