Brazil Registers Neoteryx’s Mitra Devices for Specimen Collection
by Neoteryx, on November 16,2021
November 2021 — The Mitra® microsampling device from US-based Neoteryx has been registered in Brazil as a Class 1 in vitro diagnostic (IVD) medical device by ANVISA, the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency). Allcrom, a Brazilian distributor of products and services for labs, scientists, pharmaceutical companies, and medical professionals helped get the Mitra® device registered for use in Brazil. Class 1 registration allows Mitra devices to be used for research and healthcare by governmental and private institutions, laboratories, clinics, hospitals, medical professionals, and by end-users at home.
The portable Mitra device simplifies sample collection and is ideal for remotely collecting tiny blood samples using an easy finger-stick method. Mitra is based on volumetric absorptive microsampling technology, made possible by the absorbent VAMS® tip on the end of the device. Mitra microsamples can be collected at home and sent to a designated lab via regular mail.
A recent survey conducted by Allcrom found that more than 83% of Brazilians experience some stress or anxiety related to traditional blood draws. A select group of volunteers who tried the Mitra device said it reduced their fear and they would undergo clinical exams more frequently if Mitra were offered as a blood collection option.
“Mitra® devices from Neoteryx are a revolutionary product that humanizes the specimen collection experience for users,” said Graciela Gomes, Technical Product Specialist, Allcrom. “Registration of Mitra devices in Brazil creates a new opportunity for companies to offer innovative services that will benefit our society.”
In Brazil, Allcrom will distribute Mitra devices to labs, pharmaceutical companies, hospitals, and universities, making them widely available. Brazilian citizens living in rural areas with limited resources will be able to use Mitra® Collection Kits to collect and send specimen samples from home without having to travel to labs or facilities in city centers. Online videos and illustrated instructions inside Mitra Collection Kits will guide people in using Mitra devices to collect their own precise blood samples for validated lab testing. Mitra microsamples are analyzed in labs as dried specimen samples, an approach that keeps bio-specimens stable and eliminates the need for cold shipping and storage.
“We are committed to the success and growth of Neoteryx and its Mitra® with VAMS® microsampling product line in the Brazilian market, and we know that the quality technical support provided by Allcrom will certainly help us achieve our goals,” added Gomes.
Neoteryx LLC, a medical device company in Southern California, delivers simple, quantitative and automatable microsampling solutions. Its Mitra device facilitates remote specimen collection and transport of blood and other biological fluids to improve human health, reduce laboratory costs and enable new models of care. Neoteryx’s customers include scientific researchers, laboratories and health providers working to advance telemedicine, pharmaceutical development, biotechnology research and clinical diagnostics. For more information, visit www.neoteryx.com.
Mitra devices are intended as a specimen collector and for the storage and transport of biological fluids. They are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, Brazil and China, a Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.
Allcrom is a Brazilian company that has been operating for over 33 years, offering solutions with innovative products and services for pharmaceutical companies, analytical laboratories and the medical field to meet the needs of its clients, providing improved quality of life to the society. For more information, visit www.allcrom.com.br.
Cathy Cordova, Neoteryx Marketing Director
(714) 609-8114, email@example.com
Maria Aparecida, General Manager, Allcrom
+55 11 3464 8900, firstname.lastname@example.org