COASTLINE MEDICAL MANAGEMENT, LLC

Coastline Medical Management, LLC specializes in in vitro diagnostic (IVD) test kits. Their primary focus is on rapid immunochromatographic test (ICT) devices designed for detecting multiple drugs of abuse in clinical settings. These tests are intended for point-of-care or laboratory use to provide quick results for substance abuse screening.

The company is headquartered in the United States. While the exact location isn’t specified, its operations and regulatory filings are conducted within the US, aligning with FDA requirements for medical device manufacturers.

Coastline Medical Management, LLC’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency for Class II devices, allowing healthcare providers, regulators, and other stakeholders to identify and verify the products.

The company’s devices, such as the Coastline Explorer Cup, fall under Class II classification in the FDA’s regulatory framework. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as validation of performance standards.

These test kits are designed for clinical use, including rapid screening in emergency rooms, detox facilities, or other healthcare settings where immediate results are critical. They detect multiple drugs of abuse in a user-friendly format, enabling healthcare professionals to make informed decisions quickly without waiting for laboratory confirmation.