FDA.reportPublic FDA data

Smart Biopsy™ IF Stainer

Primary DI
08800021900011
Brand
Smart Biopsy™ IF Stainer
Company
Cytogen, Inc.
Model
CST030
Published
2023-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
08800021900011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021900011088000219000118800021900011

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide stainer IVDAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827052213923cgkim@cytogenlab.com
+827052213923hjjeong@cytogenlab.com

Regulatory Flags#

DUNS number
688482626
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800021900172Cell Isolator V2CIS0602026-03-06
08800021900028Smart Biopsy™ Isolation KitCIKW102023-05-15
08800021900035Smart Biopsy™ Cell IsolatorCIS0302023-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
05700571107713DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700572034551DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700572034568DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700571112342DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
05700571112311DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07