Longhorn Vaccines and Diagnostics LLC

Longhorn Vaccines and Diagnostics LLC specializes in in vitro diagnostic (IVD) devices, specifically specimen containers and collection kits. Their portfolio includes general specimen containers with additives or media, oral/respiratory tract specimen containers, and oral/upper respiratory tract specimen collection kits—both standalone and IVD-approved clinical versions. These products are designed for collecting, preserving, and transporting biological specimens, such as the PrimeStore MTM transport medium, which maintains specimen integrity during handling.

Longhorn Vaccines and Diagnostics LLC is based in the United States, which means its devices fall under FDA jurisdiction. Since the company’s products are classified as Class II medical devices, they are subject to the FDA’s 510(k) premarket notification process, ensuring compliance with U.S. regulatory requirements before commercialization. The FDA’s Unique Device Identifier (UDI) database also includes listings for these devices, facilitating traceability and transparency in the medical device supply chain.

Longhorn Vaccines and Diagnostics LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for identifying medical devices in the U.S., ensuring standardized tracking and compliance with regulatory requirements. The inclusion of their products in this database reflects their classification as Class II devices, which require premarket notification (510(k)) clearance before market introduction.

Longhorn Vaccines and Diagnostics LLC’s devices are classified as Class II under FDA regulations. This classification applies to moderate-risk devices that require special controls beyond general controls to ensure safety and effectiveness. As a result, these products must undergo the FDA’s 510(k) premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device or providing justification for new safety and performance criteria. This classification ensures that their specimen containers and collection kits meet rigorous standards for diagnostic use.