Concentriq AP-Dx US

GUDID 00860006054519

Laboratory instrument/analyser application software IVD

Primary Device ID	00860006054519
NIH Device Record Key	7fb8b4cc-bb37-4a72-a7f2-33708840f02b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Concentriq AP-Dx
Version Model Number	4.5
Catalog Number	US
Company DUNS	079846027
Company Name	Proscia Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860006054519 [Primary]

QKQ	Digital Pathology Image Viewing And Management Software

Steralize Prior To Use	false
Device Is Sterile	false

00860006054557 - Concentriq AP-Dx-US	2025-01-23 Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology
00860006054519 - Concentriq AP-Dx	2024-09-03Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
00860006054519 - Concentriq AP-Dx	2024-09-03 Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation