Opti Medical Systems, Inc.
OPTI Medical Systems, Inc. is a subsidiary of IDEXX Laboratories, specializing in the design and manufacturing of point-of-care and laboratory diagnostic solutions. They leverage advanced technologies to develop reliable, cost-effective products that support infectious disease diagnostics, blood gas, and electrolyte analysis using optical fluorescence technology. The company is committed to providing accurate, convenient, and flexible diagnostic tools for human medicine, with a strong international presence and a history of innovative product development.
Industries
Nr. of Employees
medium (51-250)
Opti Medical Systems, Inc.
235 Hembree Park Drive, Roswell, GA 30076, USA
Patents
Spreading layer and humidity control layer for enhancing sensor performance
US-8158259-B2
View Details
Spreading layer and humidity control layer for enhancing sensor performance
US-8158259-B2
View DetailsProducts
Portable cassette-based blood gas and electrolyte analyzer (portable clinical analyzer)
Compact analyzer platform using single-use cassettes to measure blood gases, electrolytes and metabolites with customizable workflows and electronic controls for point-of-care use.
Single-use disposable assay cassettes for blood gas and electrolytes
Consumable cassettes configured to measure combinations of pH, gases, hemoglobin, oxygen saturation, electrolytes and metabolites; includes low-volume cassette formats.
Arterial blood gas collection kit
Clinical collection kit for arterial blood gas sampling designed to support accurate specimen collection for point-of-care testing.
Real-time RT-PCR test kits for SARS-CoV-2 and multiplex SARS-CoV-2/Influenza A/B
Laboratory RT-PCR test kits for detection of SARS-CoV-2 and a multiplex kit for simultaneous detection/differentiation of SARS-CoV-2, influenza A and influenza B with internal sample controls.
Nucleic-acid extraction kits (magnetic bead-based)
Magnetic bead–based DNA/RNA extraction kits intended to be used with laboratory RT-PCR workflows.
Extraction-free rapid lysis buffer protocol (sample-prep)
A validated heat-based rapid lysis buffer protocol enabling extraction-free sample preparation for RT-PCR workflows to reduce instrument, reagent and consumable requirements.
Portable cassette-based blood gas and electrolyte analyzer (portable clinical analyzer)
Compact analyzer platform using single-use cassettes to measure blood gases, electrolytes and metabolites with customizable workflows and electronic controls for point-of-care use.
Single-use disposable assay cassettes for blood gas and electrolytes
Consumable cassettes configured to measure combinations of pH, gases, hemoglobin, oxygen saturation, electrolytes and metabolites; includes low-volume cassette formats.
Arterial blood gas collection kit
Clinical collection kit for arterial blood gas sampling designed to support accurate specimen collection for point-of-care testing.
Real-time RT-PCR test kits for SARS-CoV-2 and multiplex SARS-CoV-2/Influenza A/B
Laboratory RT-PCR test kits for detection of SARS-CoV-2 and a multiplex kit for simultaneous detection/differentiation of SARS-CoV-2, influenza A and influenza B with internal sample controls.
Nucleic-acid extraction kits (magnetic bead-based)
Magnetic bead–based DNA/RNA extraction kits intended to be used with laboratory RT-PCR workflows.
Extraction-free rapid lysis buffer protocol (sample-prep)
A validated heat-based rapid lysis buffer protocol enabling extraction-free sample preparation for RT-PCR workflows to reduce instrument, reagent and consumable requirements.
Services
Secure online portal for uploading QC data from analyzers, evaluating QC trends, identifying negative trends and comparing results with peer groups.
Production and distribution of RT-PCR test kits and nucleic-acid extraction kits to support clinical laboratory testing.
Telephone and web-based technical support for instruments and assays, including dedicated technical support request process and regional contact numbers.
Internal compliance program activities including policy development, training, auditing and corrective action processes to support regulated product manufacturing and distribution.
Secure online portal for uploading QC data from analyzers, evaluating QC trends, identifying negative trends and comparing results with peer groups.
Production and distribution of RT-PCR test kits and nucleic-acid extraction kits to support clinical laboratory testing.
Telephone and web-based technical support for instruments and assays, including dedicated technical support request process and regional contact numbers.
Internal compliance program activities including policy development, training, auditing and corrective action processes to support regulated product manufacturing and distribution.
Expertise Areas
- Point-of-care blood gas and electrolyte analysis
- Molecular diagnostics and RT-PCR assay development
- Assay consumable design and manufacturing (disposable cassettes)
- Regulatory compliance and submissions for IVDs (FDA, CE, Health Canada)
Key Technologies
- Optical fluorescence sensors
- Optical reflectance measurement
- Real-time RT-PCR
- Magnetic bead nucleic-acid extraction
News & Updates
The FDA granted emergency use authorization for the OPTI SARS-CoV-2/Influenza A/B RT-PCR Test, which detects and differentiates between SARS-CoV-2, influenza A, and influenza B.
The OPTI SARS-CoV-2 RT-PCR Test received FDA EUA and CE-IVD, with a protocol that eliminates the need for extraction, increasing workflow efficiency.
The company received CE mark certification in the EU for its COVID-19 detection test kit, following validation by the Institut Pasteur of France and FDA EUA.
OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its SARS-CoV-2 RNA PCR Test Kit
The FDA granted EUA for the OPTI SARS-CoV-2 RT-PCR test kit, supporting COVID-19 testing efforts.
The FDA granted emergency use authorization for the OPTI SARS-CoV-2/Influenza A/B RT-PCR Test.
The company received CE mark certification in the EU for its COVID-19 detection test kit.
The FDA granted emergency use authorization for the OPTI SARS-CoV-2/Influenza A/B RT-PCR Test, which detects and differentiates between SARS-CoV-2, influenza A, and influenza B.
The OPTI SARS-CoV-2 RT-PCR Test received FDA EUA and CE-IVD, with a protocol that eliminates the need for extraction, increasing workflow efficiency.
The company received CE mark certification in the EU for its COVID-19 detection test kit, following validation by the Institut Pasteur of France and FDA EUA.
OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its SARS-CoV-2 RNA PCR Test Kit
The FDA granted EUA for the OPTI SARS-CoV-2 RT-PCR test kit, supporting COVID-19 testing efforts.
The FDA granted emergency use authorization for the OPTI SARS-CoV-2/Influenza A/B RT-PCR Test.
The company received CE mark certification in the EU for its COVID-19 detection test kit.