FDA.report

Microscope slide stainer IVD

Definition
An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.
GUDID devices
246
Last updated
2026-01-06 15:15:24

Related Product Codes

CodeDeviceSpecialtyClassDevices
KPASlide Stainer, AutomatedPathology1227
KEYStainer, Tissue, AutomatedPathology17
KQCStains, HematologyHematology14
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry14
JCCPh BufferPathology13
HYSLight GreenHematology11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
06979203760049Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdCW-10002025-12-29
04015630971428Light Green for PASVentana Medical Systems, Inc.052792670012025-12-15
07613336140956BenchMark GXVentana Medical Systems, Inc.058946620012025-12-15
05700575000416Dako Omnis 165 DuoAGILENT TECHNOLOGIES SINGAPORE PTE LTDGI1002025-07-01
09349458005672BOND-III Processing ModuleLEICA BIOSYSTEMS MELBOURNE PTY LTDBOND-III2025-06-30
09349458005689BOND-MAX Processing ModuleLEICA BIOSYSTEMS MELBOURNE PTY LTDBOND-MAX2025-06-30
05700575000423Dako Omnis 110AGILENT TECHNOLOGIES SINGAPORE PTE LTDGI3002025-06-25
05700575013812Dako Omnis DI Water Filling AccessoriesAGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareAGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1222025-06-25
05700575014024Dako Omnis DIW TankAGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1252025-06-25
05700575014031Dako Omnis Waste Tank (NHz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1262025-06-25
05700575014048Dako Omnis Waste Tank (Hz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGC1242025-06-25
B502BSB74000TintoStainer Plus Automated SystemBIO SB, INC.BSB-74002025-03-28
B502BSB7400100TintoStainer Plus Automated System MiniBIO SB, INC.BSB-7400-102025-03-28
B502BSB7400600TintoStainer Plus Automated System LXBIO SB, INC.BSB-7400-602025-03-28
B502BSB70000Tinto Detector Complete SystemBIO SB, INC.BSB 70002025-03-18
B502BSB70010TintoDetector Staining SystemBIO SB, INC.BSB 70012025-03-18
B502BSB70850TintoDetector MiniBIO SB, INC.BSB 70852025-03-18
08435421271890VitroStainer 42VITRO SAVIT-VS422025-02-20
08435804518970VitroStainer 42VITRO SAVIT-VS42BC2025-02-20
06971182571326Fully Automated IHC StainerDakewe (Shenzhen) Medical Equipment Co., Ltd.NS402024-12-27
09349458005665BOND-PRIME automated stainerLEICA BIOSYSTEMS MELBOURNE PTY LTDBOND-PRIME2024-10-18
09349458005634BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDPrinter Ribbon & Labels for Cognitive Cxi (6 Pack)2024-08-02
09349458005641BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDPrinter Ribbon & Labels for Cognitive Cxi (6 Pack)2024-08-02
09349458005658BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDCognitive Labeller2024-08-02
00847627033673intelliPATH MAXBIOCARE MEDICAL LLCIPMX0001INTL2024-07-17
00847627033796intelliPATH MAXBIOCARE MEDICAL LLCIPMX0001INTL-R2024-07-17
00847627033604intelliPATH MAXBIOCARE MEDICAL LLCIPMX0001US2024-04-30
00847627033666intelliPATH MAXBIOCARE MEDICAL LLCIPMX0001US-R2024-04-30
G225SS1Z0Nova AuraPathcom Systems CorporationSS1-Z2024-04-08
00860008222404ASP Device; ASP System; ROSE Prep proASP Health Inc.REV M2024-04-05
09349458005627BONDLEICA BIOSYSTEMS MELBOURNE PTY LTDZebra ZD421 Label Printer Spare2024-04-05
10860008222425ASP HOODASP Health Inc.A-032024-04-05
20860008222415ASP PODASP Health Inc.A-032024-04-05
20860008222439ASP VIALASP Health Inc.A-032024-04-05
05051663517935EprediaSHANDON DIAGNOSTICS LIMITEDTubing Assy Haz Waste2024-02-16
05051663517942EprediaSHANDON DIAGNOSTICS LIMITEDTubing Assy Non Haz Waste2024-02-16
05051663518024EprediaSHANDON DIAGNOSTICS LIMITEDReagent Rack2024-02-16
05051663518031EprediaSHANDON DIAGNOSTICS LIMITEDPC for 360 Instrument2024-02-16
05051663518048EprediaSHANDON DIAGNOSTICS LIMITEDPC for 480S Instrument2024-02-16
05051663518062EprediaSHANDON DIAGNOSTICS LIMITEDPC for 720 Instrument2024-02-16
05051663518079EprediaSHANDON DIAGNOSTICS LIMITEDReagent Barcode Label Kit2024-02-16
05051663518086EprediaSHANDON DIAGNOSTICS LIMITEDFlap Label Kit2024-02-16
05051663518093EprediaSHANDON DIAGNOSTICS LIMITED12ml Vial with Cap Kit2024-02-16
05051663518109EprediaSHANDON DIAGNOSTICS LIMITEDLV 720 Reagent Tray Kit2024-02-16
05051663518116EprediaSHANDON DIAGNOSTICS LIMITED480S Reagent Rack Kit2024-02-16
05051663518123EprediaSHANDON DIAGNOSTICS LIMITEDSlide Rack Kit2024-02-16
05051663518130EprediaSHANDON DIAGNOSTICS LIMITEDBottle Kit inc Buffer2024-02-16
05051663518147EprediaSHANDON DIAGNOSTICS LIMITEDSlide Barcode Label Kit2024-02-16
05051663518154EprediaSHANDON DIAGNOSTICS LIMITEDPC Connector Bracket Kit2024-02-16
05051663518321EprediaSHANDON DIAGNOSTICS LIMITEDTray for 40 Autostainer2024-02-16
05051663518338EprediaSHANDON DIAGNOSTICS LIMITEDReagent Bottle Rack2024-02-16
05051663504065EprediaSHANDON DIAGNOSTICS LIMITEDInlet Hose 2.5M Long2024-02-15
05051663517249EprediaSHANDON DIAGNOSTICS LIMITEDReagent Pot (Pk of 3)2024-02-15
05051663517256EprediaSHANDON DIAGNOSTICS LIMITEDMultireagent Pot Cover2024-02-15
05051663517263EprediaSHANDON DIAGNOSTICS LIMITEDSingle Reagent Pot Cover2024-02-15
05051663517270EprediaSHANDON DIAGNOSTICS LIMITEDReagent Pot Insert2024-02-15
05051663517287EprediaSHANDON DIAGNOSTICS LIMITEDSlide Rack Adaptor2024-02-15
05051663517409EprediaSHANDON DIAGNOSTICS LIMITEDGemini Baskets (5)2024-02-15
05051663517416EprediaSHANDON DIAGNOSTICS LIMITEDGemini Baskets (5)2024-02-15
05051663517591EprediaSHANDON DIAGNOSTICS LIMITEDSlide Rack Carrier2024-02-15
05051663517218EprediaSHANDON DIAGNOSTICS LIMITEDSakura Carrier (PK of 5)2024-02-14
05051663517225EprediaSHANDON DIAGNOSTICS LIMITEDBasket and Carrier2024-02-14
05051663517232EprediaSHANDON DIAGNOSTICS LIMITEDVent Adaptor Kit2024-02-14
05051663518000EprediaSHANDON DIAGNOSTICS LIMITEDEvaporation Cover2024-02-14
05051663518017EprediaSHANDON DIAGNOSTICS LIMITEDPT Tank Lid Pins and Lid2024-02-14
05051663615877EprediaSHANDON DIAGNOSTICS LIMITEDSlide Clip White (Pk of 25)2024-02-14
05051663615884EprediaSHANDON DIAGNOSTICS LIMITEDSingle Station Staining Dishes (Pk of 10)2024-02-14
00847627032775intelliPATH PlusBIOCARE MEDICAL LLCIPPLS0001INTL2024-01-03
00847627033031intelliPATH Plus BIOCARE MEDICAL LLCIPPLS0001INTL-R2024-01-03
00847627032751intelliPATH PlusBIOCARE MEDICAL LLCIPPLS0001US 2023-11-22
00847627032768intelliPATH PlusBIOCARE MEDICAL LLCIPPLS0001US-R2023-11-22
00850042030004Lumatas Automated Slide StainerLumatas Biosystems, Inc.Titan2023-10-25
00850042030011Lumatas Automated Slide StainerLumatas Biosystems, Inc.Titan S2023-10-25
03661540304590Aerospray® Cytology 12-Slide CarouselELITECHGROUP INC.AC-1952023-09-20
03661540304606Aerospray® Cytology 30-Slide CarouselELITECHGROUP INC.AC-1962023-09-20
03661540304613Stain F Empty Bottle with Level Detect, Cytology StainerELITECHGROUP INC.AC-1972023-08-17
05051663001601Thermo FisherSHANDON DIAGNOSTICS LIMITEDLINISTAT2020-09-19