Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

FDA registration

Veracyte, Inc.·2 products·🇺🇸 United States

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027084·CEP 12 SpectrumOrange

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027015·CEP 12 SpectrumOrange

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34

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

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT FFPE

FDA 510(k)

FDA Class 2 ·Immunology

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

FDA 510(k)

FDA Class 2 ·Immunology

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

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027039·ProbeChek Negative Control 0% Trisomy 8/12

Vysis

FDA UDI

ABBOTT MOLECULAR INC.·00884999027046·ProbeChek Positive Control 10% Trisomy 8/12

Early Growth Response 1 (Egr) Fish Probe Kit

FDA classification

FDA Class 2 ·Early Growth Response 1 (Egr) Fish Probe Kit