Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYS. MODEL 3039 FUNCTION PACK

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Q6 Edge

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Pride Mobility Products Corporation·1 device

MC 3FP/3FP-S Spritze

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Mytronic GmbH·154 devices

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYS. MODEL 385 G FUNCTION PACK

DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

FDA 510(k)

FDA Class 2 ·Immunology

Alpha-1-Fetoprotein (AFP); Polyclonal (Ready-To-Use) 25 mL

Device

EU IVDR · Eu Ivd Class C ·ScyTek Laboratories Inc.·On the market·1 country

Alpha-1-Fetoprotein (AFP); Polyclonal (Ready-To-Use) 7 mL

Device

EU IVDR · Eu Ivd Class C ·ScyTek Laboratories Inc.·On the market·1 country

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

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay

AFP FIA

Basic UDI-DI

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

AFP (CLIA)

Basic UDI-DI

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

AFP (CLIA)

Basic UDI-DI

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