Mycobacterium Tuberculosis（TB） IgG Antibody Assay Kit by Colloidal Gold Method

Basic UDI-DI

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

Anti-tyrosine Phosphatase 2 antibody(Anti-IA2-IgG) Detection Kit(CLIA)

Basic UDI-DI

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

SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Mole Bioscience Co., LTD.·1 device

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgG (ELISA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Hepatitis E virus(HEV) IgG Antibody Detection Kit (Magnetic Particle CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Tianjin Bioscience Diagnostic Technology Co.,Ltd.·1 device

2019-nCoV IgM/IgG Antibody (whole blood/serum/plasma) Detection Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·FARMASINO MEDICAL CO., LTD·1 device

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

FDA classification

FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

FDA classification

FDA Not Classified ·Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Anti-Ss-A Ro60 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A Ro60 Autoantibodies

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Anti-D blend monoclonal, human IgG + IgM clones: MS-26, TH-28

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·ANTITOXIN GmbH·1 device

Coronavirus COVID-19 IgG/IgM Antibody Rapid Test (Whole Blood/ Serum/Plasma)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Immuno Biotech Co., Ltd·1 device

COVID-19 Ag and IgG/IgM Ab(High Sensitivity) Combo Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

Basic UDI-DI

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

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

Basic UDI-DI

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

106MM BORING TOOL

FDA registration

Sterigenics US, LLC·3 products·🇺🇸 United States