Currently
we are manufacturing antigens of native human origin which can be used either as standards
and/or calibrators in various assay formats, or immunogens for raising antibodies
or for laboratory based research & development.
The monoclonal antibody
products will soon be available for use as reagent in diagnostic kits. All
products are delivered with guaranteed testing for mandatory viral markers as
per US-FDA methods and PCR. All products are packed in accordance with
42 CFR part 72, 49 CFR 100-99 and individual customer requirements. Product
specifications, testing, Certificate of Analysis, packaging and logistics can
be customized subjected to our R&D review and practical possibilities. | Levels
of Viral Safety Testing - All source material tested for HBsAg
(except HBsAg), Anti-HIV I/II and Anti-HCV. Only non-reactive material used for
processing
- All finished products are tested for HBsAg (except HBsAg)
, Anti-HIV I/II and Anti-HCV. Only non-reactive released
- All finished
products are also tested for absence of viral (HBV, HCV and HIV) genetic material
by PCR. NAT is possible at additional cost.
HBV not tested in HBsAg.
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