CISBIO BIOASSAYS

Cisbio Bioassays specialises in in vitro diagnostic (IVD) kits, primarily focused on hormone and enzyme assays. Their products include radioimmunoassay (RIA) tests for key biomarkers like estradiol, human growth hormone, progesterone, and trypsin. They also offer assays for aldosterone, parathyroid hormone, cortisol, and bone turnover markers such as osteocalcin and C-terminal telopeptide of type I collagen. These devices are designed for laboratory use to measure specific biological targets in clinical samples.

Cisbio Bioassays is based in France. Their devices are registered in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system, ensuring compliance with European and US regulatory requirements for IVDs.

Cisbio Bioassays’ IVD devices are primarily classified as Class I under medical device regulations. Most fall under IVD Annex II List B or IVD General categories, which are lower-risk classifications for diagnostic tests that pose minimal risk to patients. This classification is determined by factors like the device’s intended use, risk level, and potential impact on patient management.

The IVD kits from Cisbio Bioassays are developed for laboratory use to quantitatively measure specific biomarkers in patient samples. For example, their estradiol and progesterone assays help monitor hormonal levels, while enzyme assays like trypsin can assess metabolic or digestive function. These tests support clinical decision-making by providing precise diagnostic information, such as hormone imbalances or enzyme deficiencies.