AFP ELISA

FDA registration

VICTORCH MEDITEK, INC.·1 product·🇺🇸 United States

AFP Rapid Test

FDA registration

Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

AFP AccuLite® CLIA Test System (Ref 1975-300A and 1975-300B)

FDA registration

MONOBIND, INC.·1 product·🇺🇸 United States

uTASWako AFP-L3

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·04987481164390·In-Vitro Diagnostic Use

uTASWako AFP-L3 Sample Dilution Buffer

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·14987481164465·In-Vitro Diagnostic Use

uTASWako Chip Cassette

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·10856626006080·The uTASWako chip cassette is designed to be us...

uTASWako Wash Solution

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·14987481164502·In-Vitro Diagnostic Use

uTASWako DCP

FDA UDI

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

uTASWako Wash Solution

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·10856626006059·In-Vitro Diagnostic Use

uTASWako AFP-L3

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·00856626006205·In-Vitro Diagnostic Use

uTASWako DCP

FDA UDI

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

uTASWako AFP-L3 Sample Dilution Buffer

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·10856626006189·In-Vitro Diagnostic Use

uTASWako Chip Cassette

FDA UDI

FUJIFILM WAKO PURE CHEMICAL CORPORATION·14987481164427·The uTASWako chip cassette is designed to be us...

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

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

FDA 510(k)

FDA Class 2 ·Immunology

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 I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

FDA 510(k)

FDA Class 2 ·Immunology