Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Restoration, Porcelain

FDA classification

FDA Not Classified ·Restoration, Porcelain

Restoration, Noble Metal

FDA classification

FDA Not Classified ·Restoration, Noble Metal

Restoration, Base Metal

FDA classification

FDA Not Classified ·Restoration, Base Metal

Restoration, Resin, Crown And Bridge

FDA classification

FDA Not Classified ·Restoration, Resin, Crown And Bridge

CR-03-1233-860-24

Certificate

MDR QMS·Neuro Event Labs Oy·Eurofins Electric & Electronics Finland Oy

G2S0911060017

Certificate

MDD Annex V·Pharma Lab International Ltd.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

G20911060016

Certificate

MDD Annex V·Pharma Lab International Ltd.·TÜV SÜD Product Service GmbH·4 Basic UDI-DIs

Fab, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fab, Fitc, Antigen, Antiserum, Control

Fab, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fab, Rhodamine, Antigen, Antiserum, Control

FDA Pre-Market Approval

Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Restoration, Porcelain-Fused-To-Metal

FDA classification

FDA Not Classified ·Restoration, Porcelain-Fused-To-Metal

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

Igg (Fab Fragment Specific), Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Igg (Fab Fragment Specific), Antigen, Antiserum, Control

HZ 2297231-1

Certificate

MDR QMS·Smart Labs Spółka z ograniczoną odpowiedzialnością·TÜV Rheinland LGA Products GmbH

Hab Gov Strategics Applied Technologies Limited

Authorized representative

🇲🇹 Malta·2 Manufacturers·5 Devices