BioMedomics, Inc. Recertified for ISO 13485

BioMedomics, Inc. is proud to announce that the BSI Group of America has accredited and recertified our ISO 13485:2016 certification.

The certification of compliance with ISO 13485:2016 recognizes that the policies, practices and procedures of our company ensure consistent quality in the product and services we provide our clients. With this certification, our clients can be confident that BioMedomics, Inc. is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed client satisfaction.

BioMedomics, Inc. is certified as meeting the requirements of ISO 13485:2016 for the following activities:

The design, development and manufacture of in-vitro diagnostic medical devices used in the detection of hemoglobin disorders and/or adaptive immune responses including laboratory and point-of-care in-vitro diagnostic medical devices.

To maintain our certification, we will perform audits to ensure compliance and to assess initiatives for continued improvement. Our clients can be confident that BioMedomics, Inc. will continue to provide the high-quality products and services they have come to expect well into the future.

Saudi FDA Approval Announcement

BioMedomics is an ISO 13485 certified company committed to meeting unmet market needs by developing innovative point-of-care diagnostic tests which provide immediate answers to individuals and their healthcare providers.

Saudi FDA approval

SARS-CoV-2 Antigen Test Kit (LFIA) 

CE approved SARS-CoV-2 Antigen Test is a lateral flow immunoassay (LFIA) that detects the most abundant protein (NP) antigen of SARS-CoV-2 and its various mutations of concern in 15-20 minutes using a double-antibody sandwich assay.

COVID-19 IgM-IgG Antibody Rapid Test

CE approved, rapid, point-of-care COVID-19 IgM-IgG Antibody Rapid Test is one of the world’s most sensitive tests for COVID-19 delivers results in 10 minutes. It detects both early (IgM) and late (IgG) marker antibodies in human finger-prick capillary blood, venous whole blood, serum, and plasma.

BioMedomics Celebrates Sickle Cell Awareness Month

September is National Sickle Cell Awareness Month. Sickle cell disease is an inherited disease that distorts soft and round red blood cells and turns them into hard, crescent shaped cells. These distorted red blood cells can cause those affected to experience extreme pain and often requires numerous blood transfusions to increase the number of normal red blood cells in the body and unblock blood vessels. According to the American Red Cross, a patient with sickle cell disease may need up to 100 units of blood each year to treat complications from the disease.

BioMedomics would like to reaffirm our commitment to improving the quality of life and health outcomes of those affected by sickle cell disease. We encourage everyone to be part of this international effort to increase awareness about sickle cell disease and sickle cell trait. Individuals and organizations can join our efforts by donating blood, engaging elected officials for proclamations, and distributing educational information to dispel the myths about sickle cell disease.

BioMedomics™ Sickle SCAN® is a multiplexed, qualitative, point-of-care immunoassay to aid in the rapid diagnosis of sickle cell disorders. The test is made up of three indicators which detect the presence of hemoglobin A, S, and C, allowing the user to rapidly distinguish between normal, carrier, and sickle cell disease samples.

  • No electricity or instrumentation required
  • Combined sensitivity and specificity of >99%
  • Results in 5 minutes
  • Suitable for newborn screening
  • Ships worldwide

For more information, please email info@biomedomics.com. To place an order, please email sales@biomedomics.com.

BioMedomics, Inc. Recertified for ISO 13485

BioMedomics, Inc. is proud to announce that the BSI Group of America has accredited and recertified our ISO 13485:2016 certification.

The certification of compliance with ISO 13485:2016 recognizes that the policies, practices and procedures of our company ensure consistent quality in the product and services we provide our clients. With this certification, our clients can be confident that BioMedomics, Inc. is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed client satisfaction.

BioMedomics, Inc. is certified as meeting the requirements of ISO 13485:2016 for the following activities:

The design, development and manufacture of in-vitro diagnostic medical devices used in the detection of hemoglobin disorders and/or adaptive immune responses including laboratory and point-of-care in-vitro diagnostic medical devices.

To maintain our certification, we will perform audits to ensure compliance and to assess initiatives for continued improvement. Our clients can be confident that BioMedomics, Inc. will continue to provide the high-quality products and services they have come to expect well into the future.

BioMedomics, Inc.’s ISO 13485 Certification Granted Expansion

BioMedomics, Inc. is proud to announce its ISO 13485:2016 certificate has expanded in scope to include the design, development and manufacturing of COVID-19 rapid tests.  The certification is accredited by BSI Group America.

The certification of compliance with ISO 13485:2016 recognizes that the policies, practices and procedures of our company ensure consistent quality in the product and services we provide our clients. With this certification, our clients can be confident that BioMedomics, Inc. is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed client satisfaction.

BioMedomics, Inc. is certified as meeting the requirements of ISO 13485:2016 for the following activities:

The design, development and manufacture of in-vitro diagnostic medical devices used in the detection of hemoglobin disorders and/or adaptive immune responses including laboratory and point-of-care in-vitro diagnostic medical devices.

To maintain our certification, we will perform audits to ensure compliance and to assess initiatives for continued improvement. Our clients can be confident that BioMedomics, Inc. will continue to provide the high-quality products and services they have come to expect well into the future.

We believe that our decision to expand our ISO certification to include our COVID-19 product line is a proactive one that not only anticipates the demands of our clients, but also demonstrates our commitment to providing quality services to all our clients.