Miele cleaning and disinfection machine with...
LabTech Labortechnik GmbH offers you a large selection of medical technology - rinsing, cleaning and...
1 - 27 by 27 results
Sterilizers - choice and quality
LabTech Labortechnik GmbH offers you a large selection of laboratory technology - sterilizers Exampl...
ENDOZYME® II GO (Endotoxin test)
MAIN BENEFITS: Fluorescence end-point assays in 96-well microplate format with methodologie...
Hygiene in times of COVID-19 (Testing of...
Hygiene is an important commodity at all times, but especially in the current crisis situation. Desp...
Case Study: Arterial Blood Collection Vessels
Whole blood samples are taken from patients using arterial blood collection vessels. The sample is t...
R&D / LAB ANALYTICS Through our own laboratoy, we can offer a decisive benefit to our custome...
Procare liquid cleaners and powder cleaners...
LabTech Labortechnik GmbH offers you a large selection of laboratory technology - Procare liquid cle...
Tests as part of the validation of instructions...
In the same way as with processing of medical devices (cleaning and disinfection) the manufacturer o...
Large-capacity laboratory washer - laboratory...
LabTech Labortechnik GmbH offers you a large selection of laboratory technology - large laboratory w...
IVD Rapid Test Reader, ESEQuant Flex, Lateral...
Our best-in-class lateral flow readers offer a high degree of flexibility to suit your custom applic...
CLEANING MEDIA BANTLEON cooperates closely with leading plant manufacturers in order to develop i...
Tests as part of the validation of instructions...
Manufacturers and distributors of medical deviceswhich are designed for reuse, must provide informat...
Biological Safety Testing of Medical Devices
Biological Evaluation of Medical Devices / Biocompatibility TPMD provides a highly sophisticated...
Applications (detection and measurement)
High- Quality Detection and measuring devices. Wherever. Whenever We offer full flexibility &n...
Mobile and stationary UV-C emitters - disinfection...
LabTech Labortechnik GmbH offers you a large selection of laboratory technology - laboratory washers...
Fluorescence end-point assays in 96-well microplate format with methodologies simila...
Endotoxin test (as per USP 85 and Ph. Eur....
Endotoxins (ancient Greek endo: "inside", "within", toxins, "the poisonous...
Laboratory technology - laboratory washers...
LabTech Labortechnik GmbH offers you a large selection of laboratory technology - laboratory washers...
Modern diagnostic analysis methods require continuously smaller sample volumes. It brings advantages...
Upper basket for optimal accommodation of...
100 Upper basket for optimal accommodation of injector modules or inserts Upper basket with...
ENDONEXT™ Bacterial Endotoxin Testing
The Evolution of Endotoxin Detection happens now! As part of any general pyrogen testing strategy...
ENDOLISA® (Endotoxin detection)
Overcomes limitations of conventional methods, such as inhibition and enhancement...
Non-invasive sugar testing devices
Medical technology engineering & development: Non-invasive sugar testing devices are developed...
Bacterial Endotoxin & Pyrogens: Monocyte...
TPMD is accredited and GMP certified for the determination of bacterial endotoxin (BET) and non endo...
PEMICLIP® – C-arm sterile cover set orange...
PEMICLIP® – C-arm sterile cover set orange line Frame cover with 6 clips PC2, orange lines Consistin...
Point of Care (PoC) analysis for SARS-CoV-2
Point of Care (PoC) analysis If results are to be available promptly so that quick decisions can...
1 - 13 by 13 results
85092 Kösching, Deutschland
PAYER International Technologies GmbH (EN)
8151 St. Bartholomä, Österreich
86720 Nördlingen, Deutschland
72770 Reutlingen, Deutschland
Eurofins Inpac Medizintechnik GmbH (EN)
75217 Birkenfeld, Deutschland
63500 Seligenstadt, Deutschland
46395 Bocholt, Deutschland
1 - 17 by 17 results
Laboratory medicine / IVD of the area Laboratory
Products and services from the categories Laboratory medicine, laboratory medicine and IVD devices in medical technology or other healthcare-related industries .
IVDs are a vital part of laboratory medicine. They allow physicians to quickly detect disease using the least invasive, most accurate test. Many IVDs are complex and require multiple tests. Several factors must be considered in the development of an IVD. For example, a clinical study must demonstrate that a new IVD is appropriate for a particular patient. An IVD must also be compatible with other clinically used diagnostics in the laboratory.
The FDA and the Centers for Medicare & Medicaid Services (CMS) regulate IVDs. They derive authority from the Federal Food, Drug, and Cosmetics Act as well as the Public Health Service Act. Specifically, these agencies are responsible for monitoring the quality and safety of the testing process. In addition, they are responsible for ensuring that clinical laboratories are certified in accordance with applicable national and international standards. Consequently, the results of an IVD are highly accurate, reliable, and timely.
Regulations for IVDs are issued by the Food and Drug Administration (FDA). The agency has broad jurisdiction over IVDs, including their components. These reagents aid in the detection of another substance and facilitate chemical reactions. The FDA has strict requirements for IVDs developed for the commercial market. This is essential in ensuring that the tests are accurate and reliable. The FDA and CMS regulate the process and quality of laboratory diagnostics.
The FDA oversees IVDs. These medical devices must comply with regulations set by the FDA. In addition, they must meet the standards of good manufacturing practices and be free from adulteration and misbranding. The FDA also enforces stringent quality control measures for IVDs. In order to maintain high standards, the FDA has strict policies governing the manufacture and sale of medical devices. If the testing procedure is not done according to standards, the result of the test may be misleading.
In vitro diagnostics are clinical tests that analyze samples taken from the human body. The results of these tests are used to guide medical care. However, they are regulated as medical devices by the Food and Drug Administration (FDA). The FDA requires manufacturers to ensure that their IVDs meet their requirements and are useful. It is important to follow the guidelines set by the FDA for safe and effective products. These regulations are crucial for the safety of patients.
Labs are required to follow the standards for the safety and accuracy of its lab equipment. It is essential to follow these standards as they are critical to a patient's health. In addition, manufacturers must comply with all applicable quality standards and meet the requirements of regulatory bodies. Harmonization ensures a safe and effective product. All stakeholders must understand the importance of implementing a good clinical laboratory management system. By following these steps, it is possible to comply with all applicable regulatory requirements and sell products with traceability.