NYI

Product Code: NYI

Products Classified as NYI

4921

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

Gene Expression Profiling Test System For Breast Cancer Prognosis.

Total Product Life Cycle (TPLC) Devices

4921

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

Gene Expression Profiling Test System For Breast Cancer Prognosis.

Pre-market Notifications for NYI

K210973	MammaPrint FFPE NGS Kit	Agendia Inc.
K201902	MammaPrint	Agendia Inc.
K141771	PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY	NANOSTRING TECHNOLOGIES INC.
K141142	MAMMAPRINT FFPE	AGENDIA
K130010	PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY	NANOSTRING TECHNOLOGIES
K101454	MAMMAPRINT	AGENDIA
K081092	MODIFICATION TO MAMMAPRINT	AGENDIA
K080252	MODIFICATION TO MAMMAPRINT	AGENDIA BV
K070675	MAMMAPRINT	AGENDIA BV

Global Unique Device Identification Database

• 00859812006058: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
• 00859812006041: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
• 00859812006034: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
• 00859812006027: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
• 00859812006010: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer