FDA.reportPublic FDA data

eIHC IVD bundle CS2- 2500

Primary DI
00815477020051
Brand
eIHC IVD bundle CS2- 2500
Company
LEICA BIOSYSTEMS IMAGING, INC
Model
23CS2IVD-2500
Device description
Aperio ePathology IVD System CS2, includes; CS2 IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
Published
2016-09-19
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
00815477020051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815477020051008154770200518154770200510815477020051

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality clinical specimen analysis system IVDAn assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. 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
+1(866)4783999techservices@LeicaBiosystems.com

Regulatory Flags#

DUNS number
063440460
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815477020525Aperio GT 450 DX (US) Scanner23GT450DXUS2024-05-31
00815477020259Aperio AT2 DX Scanner23AT2DX2020-01-23
00815477020068eIHC IVD bundle AT Turbo-250023ATTIVD-25002016-09-19

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
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
00849832003861Leica Biosystems Ariol Rare Event 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