Clarapath, Inc.

Clarapath, Inc. specializes in in vitro diagnostic (IVD) devices primarily used in tissue sectioning and microscopy preparation. Their product line includes rotary microtomes for slicing tissue samples, single-use microtome blades designed for precision cutting, and adhesive slide coatings like mounting media and transfer tapes. These devices are engineered to streamline laboratory workflows in histology and pathology settings.

Clarapath, Inc. is headquartered in the United States. Since their devices are classified as in vitro diagnostics, they must comply with U.S. regulatory requirements, including those set by the FDA. Their products are designed and manufactured in alignment with applicable IVD regulations to ensure safety, performance, and compliance.

Clarapath, Inc.’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I IVD devices like rotary microtomes, microtome blades, and microscopy mounting media to ensure transparency and traceability in the medical device supply chain.

All of Clarapath, Inc.’s listed devices fall under FDA Class I classification. This classification applies to low-risk devices like rotary microtomes, single-use blades, and adhesive slide coatings, which are deemed to pose minimal risk to patients and users when used as intended in laboratory settings.