At BIOGEN VET, we produce a wide range of laboratory consumables for in vitro diagnostics, both standard and tailored to the most demanding requirements of our customers. We specialize in the production of Petri dishes, universal mono and multichannel pipette tips, reaction plates, deep well plates, and double-loop inoculation needles.
All our products are manufactured with the utmost attention to quality and precision, ensuring rapid and reliable diagnostics. We have a large production capacity, extensive experience, and advanced knowledge to produce high-quality laboratory consumables.
At BIOGEN VET, we view every challenge as an opportunity. That is why we are constantly striving to do better – for our customers, for our company, and for the world.
MICROBIOLOGYPETRI DISHES
Sterile and equipped with a triple-vented lid
Rigorously tested, certified, and validated
CE marked
MOLECULAR BIOLOGYUniversal Pipette Tips, Mono or Multichannel, 200 µl volume
Ultra-low retention surface
Can be used with any pipette manufacturer
Dimensional stability
Clarity
Ultra-low retention surface
ISO 8655 compliant
Autoclavable
MICROBIOLOGYINOCULATING LOOP
Equipped with a double-loop for inoculating nutrient media
Loop capacity of 1 µl and 10 µl
Made from high-quality polystyrene with a flexible loop body shape for enhanced flexibility
FREQUENTLY ASKED QUESTIONS
What are in vitro diagnostic medical devices?
According to REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, “in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples, including blood and tissue donations, derived from the human body for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological state or a congenital physical or mental impairment,
- concerning the predisposition to a medical condition or a disease,
- to determine the safety and compatibility with potential beneficiaries,
- to predict treatment response or reactions, to determine or monitor therapeutic measures.
- Sample containers are also considered to be in vitro diagnostic medical devices.
How are in vitro diagnostic devices classified?
Devices are classified into Classes A, B, C, and D, taking into account their intended purpose and inherent risks. The classification is carried out in accordance with Annex VIII.
What is the CE marking, and why is it important for IVDR medical devices?
The CE marking is a declaration by the manufacturer that their product meets the EU requirements for health, safety, and the environment. To market an IVDR medical device in the EU, manufacturers must meet the CE marking requirements.
How do you ensure that IVDR medical devices are effective and accurate?
Manufacturers of IVD medical devices perform rigorous performance validation tests to ensure their products are accurate and effective. These tests often include sensitivity and specificity testing, as well as clinical studies to validate the performance of IVD medical devices.
How should an in vitro diagnostic medical device be stored and transported?
Each in vitro diagnostic medical device may have specific storage and transportation requirements. In general, IVDR medical devices are stored under appropriate temperature and humidity conditions and transported in their original packaging to prevent damage.
