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[Product Development]
[Contract Manufacturing]
Large Scale Production
[FDA 510K Submissions]
Protein Purification
Microbiology Services
Instrumentation Development

 
     
 
 
 
   
   
 
 
 
 







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.




Product Development
Scimedx has been successful in developing niche market kits using the many different technologies... [MORE]

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]

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]

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.
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.
Instrumentation Development
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.

 

100 Ford Road Suite 100-08 Denville New Jersey USA 07834 tel 973.625.8822 toll-free 800.221.5598 fax 973.625.8796 e-mail info@scimedx.com
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