Ketobm LLC

Ketobm LLC specializes in in vitro diagnostic (IVD) reagents for measuring ketone (specifically acetoacetate) levels in blood, as well as single-use blood lancets. Their primary product, the KetoBM device, falls under these categories, designed for ketone testing in clinical or home settings.

Ketobm LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.

Ketobm LLC’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify and track specific products.

Ketobm LLC’s devices are classified as either Class I or Class II medical devices. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines regulatory oversight and compliance requirements.