FDA.reportPublic FDA data

Histostainer AT

Primary DI
G225SS1N0
Brand
Histostainer AT
Company
Pathcom Systems Corporation
Model
SS1-N
Device description
The 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 histology laboratories.
Published
2022-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPASlide Stainer, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G225SS1N0PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
845346506
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G225SS2M0Slide StainerSS2-M2026-08-26
G225SS1Z0Nova AuraSS1-Z2024-04-08
G225PATSS10MD StainerPAT-SS12022-05-01
G225QHDX360Quantum HDxQHD-X362022-05-01
G225QSSX370Quantum S2QSS-X372022-05-01
G225SS10Slide StainerSS12022-05-01
G225SS1B30Oncore ProSS1-B32022-05-01
G225SS1DBS0High LighterSS1-DBS2022-04-29
G225SS1DCS0Delta. 36SS1-DCS2022-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262400021030ColorJet NanoBio-Gram Diagnostics GmbHKPA2026-10-20
G225SS2M0Slide StainerPathcom Systems CorporationKPA2026-08-26
03760177194199RAL StainerR.A.L. DIAGNOSTICSKPA2026-07-10
00846405013999Diagnostic BioSystemsDiagnostic Biosystems, Inc.KPA2026-06-08
00846405019281Diagnostic BioSystemsDiagnostic Biosystems, Inc.KPA2026-06-05
00630414289700Atellica HEMA Slidemaker Stainer (SMS)Siemens Healthcare Diagnostics Inc.KPA2026-02-06
00380740213572AlinityABBOTT LABORATORIESKPA2025-12-25
04015630984510BenchMark Special Stains Stainer ModuleVentana Medical Systems, Inc.KPA2025-12-15
07613336140956BenchMark GXVentana Medical Systems, Inc.KPA2025-12-15
05700571112182DakoAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-09-02
05700575000416Dako Omnis 165 DuoAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-07-01
09349458005672BOND-III Processing ModuleLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2025-06-30
09349458005689BOND-MAX Processing ModuleLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2025-06-30
05700575000423Dako Omnis 110AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575013812Dako Omnis DI Water Filling AccessoriesAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014024Dako Omnis DIW TankAGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014031Dako Omnis Waste Tank (NHz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014048Dako Omnis Waste Tank (Hz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575000430Dako Omnis 165AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-24
B502BSB74000TintoStainer Plus Automated SystemBIO SB, INC.KPA2025-03-28
B502BSB7400100TintoStainer Plus Automated System MiniBIO SB, INC.KPA2025-03-28
B502BSB7400600TintoStainer Plus Automated System LXBIO SB, INC.KPA2025-03-28
08435421271890VitroStainer 42VITRO SAKPA2025-02-20
08435804518970NeoPATH ProVITRO SAKPA2025-02-20
04065271997561MIDAS® III-Plus Automated StainerSigma-Aldrich, Inc.KPA2025-01-20
06971182571326Fully Automated IHC StainerDakewe (Shenzhen) Medical Equipment Co., Ltd.KPA2024-12-27
09349458005665BOND-PRIME automated stainerLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-10-18