Nova Aura

GUDID G225SS1Z0

The Nova Aura Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in immunohistochemistry, in situ hybridization and related applications.

Pathcom Systems Corporation

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Primary Device IDG225SS1Z0
NIH Device Record Keya0abca3d-c61c-4ae3-a659-33ee1829e2d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNova Aura
Version Model NumberSS1-Z
Company DUNS845346506
Company NamePathcom Systems Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG225SS1Z0 [Primary]

FDA Product Code

KPASlide Stainer, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-16
Device Publish Date2024-04-08

Devices Manufactured by Pathcom Systems Corporation

G225SS1Z0 - Nova Aura2024-04-16The Nova Aura Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in immunohistochemistry, in situ hybridization and related applications.
G225SS1Z0 - Nova Aura2024-04-16 The Nova Aura Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sectio
G225SS1N0 - Histostainer AT2022-06-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
G225PATSS10 - MD Stainer2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
G225QHDX360 - Quantum HDx2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
G225QSSX370 - Quantum S22022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
G225SS10 - Slide Stainer2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
G225SS1B30 - Oncore Pro2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp
G225SS1DBS0 - High Lighter2022-05-09 The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytosp

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