FDA.reportPublic FDA data

RAL Stainer

Primary DI
03760177194199
Brand
RAL Stainer
Company
R.A.L. DIAGNOSTICS
Model
405000
Device description
Slide stainer automated
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
03760177194199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177194199037601771941993760177194199

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.

Regulatory Flags#

DUNS number
264611820
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760177194366RAL StainBox4020002026-07-10
03760177194694RAL SmearBox4100002026-07-10
03760177194519Ral Diff-Quik EZ-Kit (3 x 100ml)037601771945192018-09-07
03760177194526Ral Diff-Quik Kit (3 x 500ml)037601771945262018-09-07
03760177194533Ral Diff-Quik Fixative Solution (1 x 2,5L)037601771945332018-09-07
03760177194540Ral Diff-Quik Solution I (1 x 2,5L)037601771945402018-09-07
03760177194557Ral Diff-Quik Solution II (1 x 2,5L)037601771945572018-09-07

Other Devices Sharing Product Codes#

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