10,000 results · 43ms · Sources: EU EUDAMED, US FDA

uTASWako DCP

FDA UDI
FUJIFILM WAKO PURE CHEMICAL CORPORATION·00856626006120·In-Vitro Diagnostic Use

uTASWako DCP

FDA UDI
FUJIFILM WAKO PURE CHEMICAL CORPORATION·04987481164413·In-Vitro Diagnostic Use

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)
FDA Class 2 ·Immunology

uTASWako AFP-L3 Control L and H

FDA registration
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)·5 products·🇯🇵 Japan

uTASWako AFP-L3 Control L and H

FDA registration
FUJIFILM Healthcare Manufacturing Corporation MIE Office·5 products·🇯🇵 Japan

FUJIFILM Healthcare Americas Corporation

FDA registration
FUJIFILM Healthcare Americas Corporation·5 products·🇺🇸 United States

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office

FDA registration
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office·5 products·🇯🇵 Japan

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification
FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

NAU Spa

Manufacturer
🇮🇹 Italy

Phencyclidine DAU Calibrators

FDA registration
LIN-ZHI INTERNATIONAL, INC.·2 products·🇺🇸 United States

Propoxyphene DAU Calibrators

FDA registration
LIN-ZHI INTERNATIONAL, INC.·2 products·🇺🇸 United States

Mighty Oak Medical

Manufacturer
🇺🇸 United States·1 Basic UDI-DI·17 Devices

NAU S.P.A.

FDA registration
NAU S.P.A.·1 product·🇮🇹 Italy

NAU S.P.A.

FDA registration
NAU S.P.A.·1 product·🇮🇹 Italy

NAU S.P.A.

FDA registration
NAU S.P.A.·1 product·🇮🇹 Italy

Hydrocodone 100 DAU Controls

FDA registration
LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States

Barbiturate Enzyme Immunoassay

FDA registration
LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States

Oxycodone Enzyme Immunoassay

FDA registration
LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States

Norbuprenorphine DAU Controls

FDA registration
LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States

Cannabinoid DAU Calibrators

FDA registration
LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States