 TekFile
Services
 We
are a highly flexible diagnostic company, with over 25 years in the
medical diagnostic industry. Specializing in immunofluorescence, ELISA
,and membrane technologies for autoimmune and infectious diseases,
we offer an extensive test menu of assays. Within the SCIMEDX organization
is a separate group, TEKFILE SERVICES,
which provides a variety of services specifically dedicated to assisting
other companies in contract product development, contract manufacturing
and regulatory guidance. The strength of the organization is the collective
diversified experiences of the personnel in many areas of diagnostics
and biochemistry. Our long time experience with FDA regulations as
a manufacturer of medical diagnostic kits can provide a practical
approach to FDA and ISO compliance.
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Product Development
Scimedx has been successful in developing niche market kits
using the many different technologies...  [MORE]
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Contract Manufacturing
Scimedx presently performs large scale manufacturing of assay
components under it's own label and contract manufacturing.
Scimedx has automated filling, washing and aspiration equipment
for handling microplates for ELISA kits...[MORE]
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Regulatory Affairs/510 K Submissions/FDA
Compliancy
Scimedx, as an in vitro diagnostic manufacturer, must comply
with the FDA Good Manufacturing Practices guidelines. Scimedx
has generated documentation and quality systems that meet or
exceed the FDA requirements for product reliability...[MORE]
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Protein Purification
Over the years Scimedx has developed several chemical and chromatographic
isolation techniques for the preparation of high purity proteins,
peptides and antibodies for use in ELISA and membrane assays.
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Microbiology Services
A wide variety of bacterial, parasites, viruses, and yeast microorganisms
have been grown in liquid and tissue culture media. We have
experience in the tissue culture of human and animal cell lines.
Experience within our organization covers a wide variety of
tissue culture techniques for viral propagation of IFA slides
or purification of viral antigens for ELISA. |
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Instrumentation Development
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Large Scale Production
Scimedx has automated filling, washing and aspiration equipment
for handling a wide variety of manufacturing procedures. Production
lots of 10,000 kits are routinely produced. |
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