Calmark's COVID-19 instrument has been registered in India
Calmark Sweden AB's instrument, used to measure LDH levels in COVID-19 patients, has been registered by the Indian authorities. Associated tests are still under registration process. Registration of medical devices is mandatory before the sales start.
Calmark is collaborating with the company r2 Hemostasis Diagnostics India Private Ltd regarding the launch, registration and sales in the Indian market. The company has very good contacts with Indian authorities and has quickly started the registration process. Calmark's instrument "POC-Analyzer Covid" has now been registered, the associated rapid tests for LDH are still in the process.
"I am very impressed with the work r2 Hemostasis Diagnostics does for us in India", comments CEO Anna Söderlund. "They have familiarized themselves with the product in a short time and handle the contacts with the authorities and the registration process in a very efficient and professional way."
Calmark POC - Covid is a platform consisting of an instrument and a test cassette for measurement of the lactate dehydrogenase (LDH) biomarker in the blood of COVID-19 patients. Elevated levels of LDH are associated with a higher risk of severe disease and death in COVID-19 patients. The platform can be used in, e.g., emergency rooms and hospital wards to assess the required level of care.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 214 98 93
E-post: [email protected]
Calmark Sweden AB is a medical technology company that develops and markets a point-of-care (POC) analysis method with easier and faster diagnostics of medical conditions in newborns. The unique test platform consists of a portable instrument and test cassettes for various biomarkers. The first test, Neo-Bilirubin, was launched to the market in 2020. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter care chains. In less developed healthcare systems, the product will offer a decision support which is currently lacking, since the access to hospital laboratories often is limited. Calmark aims to become the global leader in POC diagnostics for newborns and, in the long term, to offer all relevant tests for the first period of life. In addition to products for newborns, Calmark sells a POC test for assessment of COVID-19 disease severity. The B share is listed on the Spotlight Stock Market and is traded under the CALMA B ticker. Read more at www.calmark.se/eng/home.
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