MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT FFPE

FDA 510(k)

FDA Class 2 ·Immunology

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MammaPrint FFPE NGS Kit

FDA 510(k)

FDA Class 2 ·Immunology

MammaPrint

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

FDA 510(k)

FDA Class 2 ·Hematology

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA classification

FDA Class 2 ·Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Electrode, Gel, Electrosurgical

FDA classification

FDA Class 2 ·Electrode, Gel, Electrosurgical

Inherited Nucleotide Repeat Disorder Dna Test

FDA classification

FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

FDA classification

FDA Class 2 ·Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers