FDA.reportPublic FDA data

Indicator

Primary DI
04049188073235
Brand
Indicator
Company
Leica Biosystems Nussloch GmbH
Model
000000014045630906
Catalog number
14045630906
Device description
Leica Biosystems Accessory
Published
2018-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
04049188073235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049188073235040491880732354049188073235

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4962241430CHS.support@LeicaBiosystems.co
+4962241430CHS.support@LeicaBiosystems.com

Regulatory Flags#

DUNS number
315539452
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049188210777ASP6025 S 230V/50-60Hz000000014049559058140495590582019-07-05
04049188210784ASP6025 S 120V/50-60Hz000000014049559068140495590682019-07-05
04049188210791ASP6025 S China000000014049559088140495590882019-07-05
04049188216397HistoCore PEGASUS000000014048858005140488580052021-11-02
04049188217769HistoCore PEGASUS Plus000000014048858007140488580072021-11-02
04049188003102Leica TP1020 VF/accessories1491020US021491020US022018-12-04
04049188003119Leica TP1020 F /accessories1491020US011491020US012018-12-04
04049188055903Basket set Leica ASP300 S000000014047643576140476435762018-12-04
04049188055965Leica ASP300 S000000014047643515140476435152018-12-04
04049188055972Leica ASP300 S - 230-240V000000014047643514140476435142018-12-04
04049188056146Leica ASP300 S - China000000014047643057140476430572018-12-04
04049188057334Basket, assy., large000000014047634782140476347822018-12-04
04049188058423Basket000000014047634194140476341942018-12-04
04049188087706Leica TP1020 with Chloroform000000014042242238140422422382018-11-16
04049188087843Tissue basket - Cone000000014042232564140422325642018-12-04
04049188087973Flexible tube 50x4000000000014042231975140422319752018-12-04
04049188087980Flexible tube 50x2000000000014042231974140422319742018-12-04
04049188088246Leica TP1020 (Double loading) Without vaccum/w000000014042231418140422314182018-11-16
04049188088253Leica TP1020 (Double loading) With fume control000000014042231416140422314162018-11-16
04049188088260Leica TP1020 (Double loading) With vacuum/ without fume control000000014042231414140422314142018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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