ZEUS Scientific Announces U.S. FDA Premarket Approvals (PMA) and Launch of its ZEUS ELISA™ Parvovirus B19 Test Systems

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Designed to significantly improve laboratory’s processing turnaround time and productivity with excellent precision and accuracy

ZEUS Scientific, a leading global diagnostic solutions company, today announced the launch of ZEUS ELISA Parvovirus B19 IgG and IgM Test Systems, following receipt of Premarket Approvals (PMA) from the U.S. Food and Drug Administration (USFDA).

ZEUS ELISA Parvovirus B19 Test Systems are the latest addition to the company’s market leading range of infectious disease diagnostic solutions with seamless integration into the ZEUS ELISA menu of Test Systems, which feature:

  •     Universal reagents and protocol making it quick and easy to program and multi-batch assays on open automation platforms
  •     Assay protocol with more flexible incubation times than any other currently available ELISA method.
  •     Quick adoption into the lab due to minimal training, enabling in-house testing

Laboratories, until now, only had a single option for Parvovirus B19 testing which, due to its stringent protocol, was prohibitive for many to offer in-house testing. ZEUS ELISA Parvovirus Test Systems offer a much more efficient and cost effective alternative due to:

  •     Patient samples tested in singlicate, saving time while reducing cost
  •     Ready-to-use components
  •     Samples prepared in a dilution plate (single step sample dilution)
  •     IgG-removal diluent for accurate detection of IgM antibodies

ZEUS Scientific designed the ZEUS ELISA Parvovirus B19 Test Systems to address the challenges faced by our customers, allowing a reduction in their send-out testing volume. “The ZEUS Parvovirus B19 Test Systems demonstrate our continuing commitment to expanding our infectious disease diagnostic test menu, while addressing the needs of our customers,” said Chris Howard, Chief Commercial Officer, ZEUS Scientific. “These two new products allow clinical laboratories to easily and efficiently run these tests in house and reduce the burdens which previously led to many laboratories sending these tests out to reference laboratories. Once again, ZEUS Scientific represents the first and best choice for running infectious disease and autoimmune disease tests in the clinical diagnostic testing lab.”

ZEUS ELISA Parvovirus B19 Test Systems are already available for sale in Europe and Canada, and following the U.S. launch, will be rolled out in additional markets.

For more information, please visit http://www.zeusscientific.com, or email sales(at)zeusscientific.com.

About ZEUS Scientific

ZEUS Scientific is your first choice for high-performing, easy-to-use clinical diagnostic solutions. Our products are designed and manufactured to ensure optimal efficiency and accurate diagnosis to facilitate better patient care. ZEUS Scientific is based in Branchburg, New Jersey and markets test systems around the world through an extensive distribution network. ZEUS complies with the international standard ISO 13485 (2003), Health Canada Medical Device Regulations (SOR/98-282, May 7 1998), the FDA Quality System Regulations (FDA Quality System Regulation, 1996: 21 CFR § 820), and the IVD 98/79/EEC.

For more information visit: http://www.zeusscientific.com or call +1 (800) 286 2111.

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