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
OTC
false
Sterile
false
Single use
false

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999techservices@LeicaBiosystems.com

Regulatory Flags#

DUNS number
063440460
Device count
1
DM exempt
false
Premarket exempt
false
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
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