TAKAHASHI KEISEI CORPORATION

Takahashi Keisei Corporation specializes in urine specimen collection kits intended for in vitro diagnostic (IVD) use. These devices are designed to collect urine samples for subsequent laboratory analysis, ensuring proper specimen handling before testing. The company’s focus is on this specific category of diagnostic tools.

The company is headquartered in the United States. This location aligns with its regulatory obligations under US medical device laws, including compliance with the FDA’s requirements for its products.

Takahashi Keisei Corporation’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability in the supply chain.

The company’s urine specimen collection kits fall under Class I device classification in the US. This classification is typically assigned to low-risk devices where general controls (such as good manufacturing practices) are sufficient to ensure safety and effectiveness. Class I devices often require less stringent premarket review.