in-vitro-diagnostic Downloads
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Forcing molecules into a nanochannel, limiting the travel distance to a few hundred nanometres and reducing incubation time to 2 ...
METAglut1™ is an in Vitro Diagnostic Medical Device used to aid in the diagnosis of the GLUT1 Deficiency Syndrome (GLUT1DS). It is a regulated health product that bears the CE mark. The first test for the daily practice developed from the METAdiag platform. ...
The SARS-CoV-2 IgM ELISA kit is an in vitro diagnostic test for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum. The kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARSCoV- 2, indicating recent or prior ...
The IVD CAPSULE Aeroallergens is the first rapid, single-use in vitro diagnostic test for the quantitative determination of circulating immunoglobulin E (IgE) specific to the allergen components Phl p 1 + Phl p 5 (combined), Der p 1 + Der p 2 (combined), Alt a 1, Fel d 1 and Can f 1 in uncoagulated human capillary blood collected from the patient’s ...
The IVD CAPSULE Ferritin is a rapid, single-use in vitro diagnostic test for the quantitative measurement of ferritin in capillary and venous whole blood, to aid blood diagnostic testing for iron deficiency in ...
The IVD CAPSULE PSP is a rapid, single-use in vitro diagnostic test for the determination of Pancreatic Stone Protein (PSP) in blood for the calculation of the cSOFA score at the point of care. The cSOFA score is used to assess the severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in ...
The IVD CAPSULE PSP is a rapid, single-use in vitro diagnostic test for the quantitative measurement of pancreatic stone protein (PSP) in blood. The test is intended to be used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of nosocomial sepsis in ...
Entire CE-IVD product range for in vitro diagnostic ...
The IVD CAPSULE COVID-19 is a rapid, single-use in vitro diagnostic test that measures the presence of a specific SARS-CoV-2 viral antigen in saliva. Abionic’s COVID-19 saliva test allows for ultra-fast screening of COVID-19 patients at the point-of-care with lab quality ...
cate of compliance with EU directive 93/42/EWG (medical devices) and 98/79/EWG (in vitro diagnostics). Intellectual PropertyAs a side product of intense development efforts, innovations are continuously generated and protected by roughly 30 patents and utility patents.FDA-ApprovalWe are inspected on a regular basis by the FDA, always with positive outcome.Our ...
TÜV Rheinland Product Safety GmbH as a “Notified Body” for all medical devices, including active implantable medical devices and in-vitro diagnostic medical devices, TÜV is the partner you are looking for.TÜV can offer certification for products and quality management systems for medical device manufacturers doing business in the international ...
Interfacer middleware for Invitro diagnostic device interfacing. Interfacer is a configurable middleware for interfacing clinical diagnostic ...
The Logix Smart™ Mycobacteria Tuberculosis (MTB) Test is the first test built using our CoPrimer™ technology to receive regulatory clearance for use as an in vitro diagnostic. It is designed to detect the presence or absence of deoxyribonucleic acid (DNA) of mycobacteria tuberculosis complex ...
The AltoStar Purification Kit 1.5 uses magnetic particle technology and is intended to be used for automated isolation and purification of nucleic acids from specified human specimens for in vitro diagnostic purposes. It permits simultaneous purification of RNA and DNA from multiple sample types. ...
LumiQuick Diagnostics Inc., located in the heart of Silicon Valley, California USA, develops, manufactures and markets high quality point of care tests and other immunoassay kits for the world-wide In vitro diagnostic ...
The DRG Anti Ovarian Ab ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against oocytes in human serum. ...
Quantitative immunoassay analyzing instrument that utilizes disposable cartridge to provide in vitro diagnostics ...
The DRG Estradiol CLIA is a chemiluminescence immunoassay for the quantitative in vitro diagnostic measurement of Estradiol in serum and plasma. ...
Magnosphere™ are magnetic microparticles which can be used for life science research and in vitro diagnostic use. Available are two different type of surface characteristics; hydrophilic (MS) and hydrophobic (MX), and both chemically-functionalized products and bio-functionalized ...
The DRG Cortisol CLIA is a chemiluminescence immunoassay for the quantitative in vitro diagnostic measurement of Cortisol in serum and plasma (EDTA, heparin). ...