ZYTOVISION GMBH

FDA Device Registration & Listing · Bremerhaven Bremen, DE · Registration 3005704042

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005704042
FEI Number
3005704042
Entity Name
ZYTOVISION GMBH
City/State/Country
Bremerhaven Bremen, DE
Establishment Address
Fischkai 1, Bremerhaven Bremen 27572, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ZytoVision GmbH (Owner Number: 10045618)
Owner / Operator Contact Address
Fischkai 1, Bremerhaven, DE-HB 27572, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Nuclear Green Solution DAB Solution A ZytoDot AP-Red Solution Set HRP/AP-Polymer-Mix ZytoLight FISH-Cytology Implementation Kit HRP-Green Solution A Formaldehyde Dilution Buffer Set Anti-DIG/DNP-Mix 20x Wash Buffer TBS Detection Solution 25x Wash Buffer A Anti-Biotin/DIG-Mix Anti-Mouse-HRP-Polymer PBS/Tween Mayer's Hematoxylin Solution ZytoDot 2C CISH Implementation Kit AP-Red Solution B Mounting Solution (aqueous) Permanent Red Solution A Blue Spot Solution Nuclear Blue Solution Permanent Red Solution B ZyBlack Quenching Solution VisionArray MultiScan Software Cytology Pepsin Solution DAPI/DuraTect-Solution Heat Pretreatment Solution Citric VisionArray Myco Chip 2 HRP-Green Solution B 100x Wash Buffer Pepsin Solution ZytoDot HRP-Green Solution Set AP-Red Solution A 5x FlexISH Wash Buffer DAPI/DuraTect-Solution (ultra) Hybridization Solution Mounting Solution (alcoholic) ZytoFast PLUS CISH Implementation Kit HRP-DAB Blocking Solution 10x PBS DAB Solution Set Heat Pretreatment Solution EDTA Cytology Wash Buffer SSC DAB Solution B VisionArray Detection Kit NBT/BCIP Solution ZytoLight FISH-Tissue Implementation Kit AEC Solution Cytology Stringency Wash Buffer SSC Mouse-anti-DIG ZytoDot CISH Implementation Kit Wash Buffer SSC 10x MgCl2 FlexISH-Tissue Implementation Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2013-12-09

Official Correspondent

Julian Schmidt

US Agent Details

Mindy McCann Business: Qserve Group US Inc Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

ZytoVision GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005704042. Last updated year: 2026. Please use registration number 3005704042 when referencing this establishment in official correspondence.
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