Cytogen, Inc.

Cytogen, Inc. specializes in laboratory instruments and reagents for blood cell processing and pathology workflows. Their devices include automated and manual blood cell diluters, microscope slide stainers for in vitro diagnostic (IVD) use, and reagents that separate red blood cells. They also produce kits and instruments for isolating cells from biopsy samples, such as the Smart Biopsy™ Cell Isolator and IF Stainer, which assist in pathology testing.

Cytogen, Inc. is headquartered in the United States. Their devices are authorised for commercial distribution in the US, where they are regulated under the FDA’s framework. The company’s products are designed for laboratory and pathology applications within this market.

Cytogen, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which include Cytogen’s blood cell processing instruments, stainers, and biopsy-related products.

Cytogen, Inc.’s devices fall under Class I classification in the FDA’s regulatory framework. This classification is typically assigned to low-risk devices that pose minimal potential harm to users. The company’s blood cell diluters, slide stainers, and biopsy isolation kits are all categorised as Class I, reflecting their intended use in controlled laboratory settings.