SARS_CoV-2 Detection Kits | qRT-PCR Covid-19 Detection Kits | Genomicss

COVID-19 IgG/IgM Rapid Test | SARs-COV-2-RT-PCR Detection Kit | Swabs And Specimen Containers

Company

American BioSources Inc d/b/a Genomic Diagnostics is a healthcare company based in the United States that operates  worldwide under two divisions: Biopharmaceuticals and Diagnostics. Genomic Diagnostics is a privately held company with headquartered in Washington, New Jersey, United States of America.

 

Genomic Diagnostics researches, develops and manufactures bacterial and viral diagnostic kits such as COVID-19 IgG/IgM Rapid Test Kits, SARs-COV-2-RT-PCR Detection Kits, Swabs and Specimen Containers, reagents, reference standards for research and medical diagnostic applications.

Genomic Diagnostics

Products

Genomic Diagnostics Products

We are partnering with a number of diagnostic research and development companies, institutions, Academic institutions and Industry partners.

We have entered a JV partnership with European molecular diagnostics company to develop, qualify and validate for launching qRTPCR quantitative and qualitative test for Coronavirus (COVID-19), currently under the EUA -FDA approval process.

We are currently distributing COVID-19 IgG/IgM Rapid Test Kits, SARs-COV-2-RT-PCR Detection Kits, Swabs and Specimen Containers.

Our Services

We serve CLIA Testing Diagnostic Labs, Health Care Providers, Physicians, Biomedical Researchers, Scientists, Laboratory Technologists, Regulatory Agencies (US-FDA/EMA/WHO/MHRA/ANVISA and Other Regulatory Bodies). We bring extensive experience in CLI, CAP, GLP, GMP, and GCC.

We are currently distributing COVID-19 IgG/IgM Rapid Test Kits, SARs-COV-2-RT-PCR Detection Kits, Swabs and Specimen Containers.

  • Kit development, design, method validation, reagents qualification, equipment qualification, Quality By Design, Quality Management Systems for Devices, Quality Risk Management, Continuous Improvement (Six Sigma Methodologies).
  • Provide CLIA/CAP, GLP, GCP, GMP Services
  • Validation of facilities, Equipment, and Analytical Methods
  • All areas of Microbiology including Environmental Monitoring, and Sterility Manufacturing and Assurance
  • Follow and Train in Compliance with Biological Safety: BSL -1 to BSL-4 Classification
  • Solve the problems in a timely and cost-effective manner
  • Help develop and submit regulatory for approvals
  • We work with our client’s needs, budget and timelines
  • Our experts train in diagnostic kit usage, BSL safety, analysis and data interpretation
  • Validated Software and training
  • Regulatory package preparation and submission
  • Quality Management Systems and Quality Risk Management
  • AE complaints are investigated in a timely manner and report closure
  • Reference reagents development, standardization, qualification
  • Continuous Improvements
  • Validation of test methods
  • Qualification of Equipment
  • 21 CFR Part 11
  • Data Integrity, reliability, compliance

Contact Us

Please fill out the form below to let us know how we can be of assistance or give us a call

 Send Us an Email or Call us @ +1 (908) 674-8008

PRODUCTS

CONTACT US

DISTRIBUTORS

Email

Info@Genomicss.com

Phone

+1 (908) 674-8008
Kumar & Ballal Exim Private Limited
Ganesh Mahal Complex
K S Rao Road
Mangalore-1
Karnataka, INDIA
For South East Asia & India distribution, please contact
Chetan Ravnikar
Vice President

 Chetan.R@genomicss.com

 +1 (408) 597 6042