Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·HER2 CISH pharmDX Kit

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Implantable Pulse Generators (IPG) Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azu

Continuous, Ventilator, Home Use

FDA classification

FDA Class 2 ·Continuous, Ventilator, Home Use

Hemoglobin electrophoresis kit 100 tests 4 samples

Basic UDI-DI

EU IVDD · Eu Ivd General ·Seleo S.r.l.·1 device

System, Test, Sodium, Enzymatic Method

FDA classification

FDA Class 2 ·System, Test, Sodium, Enzymatic Method

Plug, Punctum

FDA classification

FDA Unclassified ·Plug, Punctum

System, Test, Her-2/Neu, Ihc

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Ihc

System, Test, Her-2/Neu, Monitoring

FDA classification

FDA Class 2 ·System, Test, Her-2/Neu, Monitoring

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

HUMISS TRADING S. L.

Authorized representative

🇪🇸 Spain·31 Manufacturers·188 Devices

KTR Europe GmbH

Authorized representative

🇩🇪 Germany·135 Manufacturers·3461 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices