eIHC IVD bundle AT Turbo-2500
- Primary DI
- 00815477020068
- Brand
- eIHC IVD bundle AT Turbo-2500
- Company
- LEICA BIOSYSTEMS IMAGING, INC
- Model
- 23ATTIVD-2500
- Device description
- The Aperio ePathology elHC IVD System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded neoplastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
- Published
- 2016-09-19
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
leicabiosystems.comProduct Codes#
| Code | Name |
|---|---|
| NQN | MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | Hematology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00815477020068 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00815477020068 | 00815477020068 | 815477020068 | 0815477020068 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multi-modality clinical specimen analysis system IVD | An 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 |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 |
Contacts#
| Phone | |
|---|---|
| +1 844 534 2262 | Tech.Support@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 | Catalog | Published |
|---|---|---|---|---|
| 00815477020686 | Aperio GT 180 DX | 23GT180DXUS | 2026-10-22 | |
| 00815477020693 | Aperio iQC DX Software | 23iQCDXUS | 2026-10-22 | |
| 00815477020259 | Aperio AT2 DX Scanner | 23AT2DX | 2020-01-23 | |
| 00815477020051 | eIHC IVD bundle CS2- 2500 | 23CS2IVD-2500 | 2016-09-19 | |
| 00815477020525 | Aperio GT 450 DX (US) Scanner | 23GT450DXUS | 2024-05-31 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07290016630046 | ASI IVD System | APPLIED SPECTRAL IMAGING LTD. | NQN | 2024-07-02 |
| 07290016630039 | ASI IVD System | APPLIED SPECTRAL IMAGING LTD. | NQN | 2022-03-21 |
| 07290016630015 | GenASIs™ System | APPLIED SPECTRAL IMAGING LTD. | NQN | 2018-01-25 |
| 00849832011606 | Leica Biosystems Ariol SL200 Stage | Leica Biosystems Richmond, Inc. | NQN | 2017-04-21 |
| 00849832011576 | Leica Biosystems Ariol Cable, stage sensor | Leica Biosystems Richmond, Inc. | NQN | 2017-03-29 |
| 00849832011514 | Leica Biosystems Ariol PL220 Automatic Oiler | Leica Biosystems Richmond, Inc. | NQN | 2017-03-14 |
| 00849832011491 | Leica Biosystems Lamp Housing 107, 12V 100W, 1 Lens | Leica Biosystems Richmond, Inc. | NQN | 2017-02-27 |
| 00849832011378 | Leica Biosystems Ariol Y and Z Axis Drive Belts (2 Belts),SL200 | Leica Biosystems Richmond, Inc. | NQN | 2017-01-18 |
| 07290016630008 | GenASIs™ System | APPLIED SPECTRAL IMAGING LTD. | NQN | 2017-01-12 |
| 00849832011361 | Leica Biosystems Ariol Beveled Edge Slide Holder | Leica Biosystems Richmond, Inc. | NQN | 2016-12-02 |
| 04015630985043 | VIRTUOSO System for IHC | VENTANA MEDICAL SYSTEMS, INC. | NQN | 2016-09-24 |
| 00849832007845 | Leica Biosystems Ariol TMA Module | Leica Biosystems Richmond, Inc. | NQN | 2016-09-19 |
| 00815477020051 | eIHC IVD bundle CS2- 2500 | LEICA BIOSYSTEMS IMAGING, INC | NQN | 2016-09-19 |
| 00849832003809 | Leica Biosystems Ariol DM6000B Workstation | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003816 | Leica Ariol SL200 Basw Workstation | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003823 | Leica Biosystems Ariol Review Station | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003830 | Leica Biosystems Ariol Review Software | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003847 | Leica Biosystems Ariol Fluorescent Module | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003854 | Leica Biosystems Ariol IHC Module | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003861 | Leica Biosystems Ariol Rare Event Module | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832003878 | Leica Biosystems Ariol Workstation PC for Legacy Harware | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007814 | Leica Biosystems Ariol Slide Exporter (SCN for DIH) | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007821 | Leica Biosystems Ariol Batch Processing Module | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007852 | Leica Biosystems Ariol Barcode Roll | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007869 | Leica Biosystems Ariol Small Stage 4 Slides | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007876 | Leica Biosystems Ariol Large Stage 8 slides | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007883 | Leica Biosystems Ariol Camera Large, Jai CVM2 | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007890 | Leica Biosystems Ariol Camera Small, Jai CVM4 | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007906 | Leica Biosystems Ariol 200 Slide loader | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |
| 00849832007913 | Leica Biosystems Ariol Automatic Oiler | Leica Biosystems Richmond, Inc. | NQN | 2016-09-17 |