FDA.reportPublic FDA data

Leica Biosystems Ariol Rare Event Module

Primary DI
00849832003861
Brand
Leica Biosystems Ariol Rare Event Module
Company
Leica Biosystems Richmond, Inc.
Model
23ASWRE
Device description
Leica Biosystems Ariol Rare Event Module
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQNMICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent PositivityHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832003861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832003861008498320038618498320038610849832003861

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

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
+1(866)4783999tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849832027819Leica Biosystems380320038032002026-05-22
20849832027915Leica Biosystems39LP-200-239LP-200-22026-05-13
20849832027946Leica Biosystems39LP-200-539LP-200-52026-05-13
20849832027908Leica Biosystems39LP-200-139LP-200-12026-05-12
20849832027922Leica Biosystems39LP-200-339LP-200-32026-05-12
20849832027939Leica Biosystems39LP-200-439LP-200-42026-05-12
20849832027953Leica Biosystems39LP-200-639LP-200-62026-05-12
20849832027960Leica Biosystems39LP-200-739LP-200-72026-05-12
20849832027977Leica Biosystems39LP-300-039LP-300-02026-05-12
20849832027984Leica Biosystems39LP-300-139LP-300-12026-05-12
20849832027991Leica Biosystems39LP-300-239LP-300-22026-05-12
20849832028004Leica Biosystems39LP-300-339LP-300-32026-05-12
20849832028011Leica Biosystems39LP-300-439LP-300-42026-05-12
20849832028028Leica Biosystems39LP-300-539LP-300-52026-05-12
20849832028035Leica Biosystems39LP-300-639LP-300-62026-05-12
20849832028042Leica Biosystems39LP-300-739LP-300-72026-05-12
20849832028059Leica Biosystems39LP-400-039LP-400-02026-05-12
20849832028066Leica Biosystems39LP-400-139LP-400-12026-05-12
20849832028073Leica Biosystems39LP-400-239LP-400-22026-05-12
20849832028080Leica Biosystems39LP-400-339LP-400-32026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NQN2024-07-02
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NQN2022-03-21
07290016630015GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.NQN2018-01-25
00849832011606Leica Biosystems Ariol SL200 StageLeica Biosystems Richmond, Inc.NQN2017-04-21
00849832011576Leica Biosystems Ariol Cable, stage sensorLeica Biosystems Richmond, Inc.NQN2017-03-29
00849832011514Leica Biosystems Ariol PL220 Automatic OilerLeica Biosystems Richmond, Inc.NQN2017-03-14
00849832011491Leica Biosystems Lamp Housing 107, 12V 100W, 1 LensLeica Biosystems Richmond, Inc.NQN2017-02-27
00849832011378Leica Biosystems Ariol Y and Z Axis Drive Belts (2 Belts),SL200Leica Biosystems Richmond, Inc.NQN2017-01-18
07290016630008GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.NQN2017-01-12
00849832011361Leica Biosystems Ariol Beveled Edge Slide HolderLeica Biosystems Richmond, Inc.NQN2016-12-02
04015630985043VIRTUOSO System for IHCVENTANA MEDICAL SYSTEMS, INC.NQN2016-09-24
00849832007845Leica Biosystems Ariol TMA ModuleLeica Biosystems Richmond, Inc.NQN2016-09-19
00815477020051eIHC IVD bundle CS2- 2500LEICA BIOSYSTEMS IMAGING, INCNQN2016-09-19
00815477020068eIHC IVD bundle AT Turbo-2500LEICA BIOSYSTEMS IMAGING, INCNQN2016-09-19
00849832003809Leica Biosystems Ariol DM6000B WorkstationLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832003816Leica Ariol SL200 Basw WorkstationLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832003823Leica Biosystems Ariol Review StationLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832003830Leica Biosystems Ariol Review SoftwareLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832003847Leica Biosystems Ariol Fluorescent ModuleLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832003854Leica Biosystems Ariol IHC ModuleLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832003878Leica Biosystems Ariol Workstation PC for Legacy HarwareLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832007814Leica Biosystems Ariol Slide Exporter (SCN for DIH)Leica Biosystems Richmond, Inc.NQN2016-09-17
00849832007821Leica Biosystems Ariol Batch Processing ModuleLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832007852Leica Biosystems Ariol Barcode RollLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832007869Leica Biosystems Ariol Small Stage 4 SlidesLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832007876Leica Biosystems Ariol Large Stage 8 slidesLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832007883Leica Biosystems Ariol Camera Large, Jai CVM2Leica Biosystems Richmond, Inc.NQN2016-09-17
00849832007890Leica Biosystems Ariol Camera Small, Jai CVM4Leica Biosystems Richmond, Inc.NQN2016-09-17
00849832007906Leica Biosystems Ariol 200 Slide loaderLeica Biosystems Richmond, Inc.NQN2016-09-17
00849832007913Leica Biosystems Ariol Automatic OilerLeica Biosystems Richmond, Inc.NQN2016-09-17