Alpha-fetoprotein (AFP) Test Kit (Fluorescence Immunochromatographic Assay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

FAP-First Aid Products GmbH

Importer

🇩🇪 Germany

Carcinoembryonic Antigen (CEA)/Alpha-Fetoprotein (AFP) Diagnostic Kit (TRFIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Darui Biotechnology Co., Ltd.·1 device

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON TB GOLD IN TUBE

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T SPOT-TB TEST

Access AFP (300 test kit) Reagent Packs with Calibrators(OUS)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Radioimmunoassay, Immunoreactive Insulin

FDA classification

FDA Class 1 ·Radioimmunoassay, Immunoreactive Insulin

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

FDA classification

FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA XPRESS HAFP TEST SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification

FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Digital Pathology Image Viewing And Management Software

FDA classification

FDA Class 2 ·Digital Pathology Image Viewing And Management Software

Braf Mutation Kit

FDA classification

FDA Not Classified ·Braf Mutation Kit

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System