NQN

Product Code: NQN

Products Classified as NQN

4903

Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

Immunohistochemistry Reagents And Kits.

Total Product Life Cycle (TPLC) Devices

4903

Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

Immunohistochemistry Reagents And Kits.

FDA Consensus Standards

• Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity [29272]: 21 CFR §864.1860 🔎

Pre-market Notifications for NQN

K140957	GENASIS HIPATH IHC FAMILY	APPLIED SPECTRAL IMAGING LTD.
K140465	VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER	VENTANA MEDICAL SYSTEMS, INC.
K130515	VIRTUOSO SYSTEM FOR IHC ER (SPI)	VENTANA MEDICAL SYSTEMS, INC.
K122143	VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER	VENTANA MEDICAL SYSTEMS, INC.
K121516	VIRTUOSO SYSTEM FOR IHC HER2 (4B5)	VENTANA MEDICAL SYSTEMS, INC.
K111869	VIRTUOSO SYSTEM FOR IHC PR (IE2)	VENTANA MEDICAL SYSTEMS, INC.
K092333	PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67	BIOIMAGENE, INC.
K073677	SCANSCOPE XT SYSTEM	APERIO TECHNOLOGIES
K062428	VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS	TRIPATH IMAGING, INC.
K061613	VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)	TRIPATH IMAGING
K050012	VENTANA IMAGE ANALYSIS SYSTEM	TRIPATH IMAGING, INC.
K033200	ARIOL	APPLIED IMAGING CORP.
K031363	QCA (VERSION 3.1)	CELL ANALYSIS, INC.

Global Unique Device Identification Database

• 00815477020068: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00815477020051: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832011606: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832011576: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832011514: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832011491: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832011378: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832011361: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832010425: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832010418: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832010340: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832010333: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832009597: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832009580: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
• 00849832009511: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY

Maude Adverse Events

CONFIRM ER	VENTANA MEDICAL SYSTEMS INC	2017-05-25
BENCHMARK XT	VENTANA MEDICAL SYSTEMS, INC	2016-05-31
FOCAL POINT	TRIPATH IMAGING, INC.	2006-02-09