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Quidel gets FDA nod for Solana RSV + hMPV assay
By MDBR Staff Writer
Diagnostic testing solutions provider Quidel has secured approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) assay.
Diagnostics > In Vitro Diagnostics > News
Roche gets FDA approval for cobas Zika test
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has approved Roche’s new qualitative nucleic acid test to detect Zika virus in blood donations.
Diagnostics > In Vitro Diagnostics > News
Alere i Influenza A & B 2 rapid molecular test gets FDA clearance
Alere announced that its i Influenza A & B 2 test has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for the detection of influenza A and B infection in children and adults.
Diagnostics > In Vitro Diagnostics > News
Mologic gets CE Mark for BVPro point-of-care diagnostic for patients with bacterial vaginosis
Mologic has received CE mark approval for BVPro, a rapid point-of-care test for patients presenting with symptoms of vaginosis.
Diagnostics > In Vitro Diagnostics > News
Logiciel de contrôle et supervision pour installations de stérilisation à l’EtO
Fabricant d'équipements de stérilisation à l'oxyde d'éthylène (EtO), STERISYS a développé son propre logiciel de supervision conformément aux directives GAMP 5 et FDA 21 CFR Part 11. Celui-ci permet de contrôler l'ensemble d'une installation à partir d'une seule IHM.
Diagnostics > In Vitro Diagnostics > Press Releases
SHL to Showcase Latest Innovations at PDA Universe of Pre-filled Syringes & Injection Devices
SHL Group is to present its range of new devices and innovative technologies at the 2017 Parenteral Drug Association Universe of Pre-filled Syringes and Injection Devices.
Diagnostics > In Vitro Diagnostics > Press Releases

MDBR Supplier Recommendations

STERISYS - Your Solution and Service Provider for Industrial Sterilisation
STERISYS is the European leader in industrial EO sterilisation and offers a wide range of solutions to medical device manufacturers and sterilisation service providers.... Diagnostics > In Vitro Diagnostics > Suppliers
LRE Medical - Transforming Ideas into Successful Products for 50+ Years!
LRE Medical GmbH, founded in 1961, is part of the Esterline Technologies Group. It is an award-winning full-service contract provider with creative ideas, expert market knowledge and 50+ years of experience in design, development and manufacturing of precision instrumentation (laboratory, molecular diagnostics, point-of-care, handheld) around existing and innovative technologies.... Diagnostics > In Vitro Diagnostics > Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Diagnostics > In Vitro Diagnostics > Suppliers
See more

MDBR White Paper Recommendations

SHL Group: Auto Injectors - From Planning to Launch By SHL Group
Preparing for the overall development process.... Diagnostics > In Vitro Diagnostics > White Papers See more
1-15 of 3402 results