JUBILANT HOLLISTERSTIER LLC

Jubilant HollisterStier LLC specializes in disposable devices used for intradermal allergy testing. Their products include allergy testing lancets like the Prick Lancetter™, multiple skin test systems such as the ComforTen® and Quintest® devices, skin test reservoirs, and covered trays (e.g., ComforTen® 30-hole or 60-hole trays). These items are designed for single-use or reusable applications in dermatological diagnostics, enabling controlled allergen application to assess patient reactions.

Jubilant HollisterStier LLC is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including the UDI (Unique Device Identification) system. The company’s products are listed in the FDA’s UDI database, which helps ensure traceability and compliance with U.S. regulatory requirements for medical devices. This registration supports transparency in the supply chain and adherence to safety standards.

Jubilant HollisterStier LLC’s devices are listed in the FDA’s UDI (Unique Device Identification) registry. This registry is critical because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring compliance with U.S. regulatory requirements. Listing in the UDI system helps streamline recalls, post-market surveillance, and device traceability, which are essential for patient safety and operational efficiency in healthcare settings.

Jubilant HollisterStier LLC’s devices fall under the FDA’s Class II classification. Class II devices require special controls beyond general controls (like good manufacturing practices) to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements. The classification reflects the moderate risk associated with allergy testing devices, which must be carefully designed and validated to minimize patient risk while enabling accurate diagnostic procedures.