eIHC IVD bundle AT Turbo-2500

GUDID 00815477020068

Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500

LEICA BIOSYSTEMS IMAGING, INC

Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD

• Primary Device ID: 00815477020068
• NIH Device Record Key: 76fce926-a237-4fad-9f17-ca24d2dd8be8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eIHC IVD bundle AT Turbo-2500
• Version Model Number: 23ATTIVD-2500
• Company DUNS: 063440460
• Company Name: LEICA BIOSYSTEMS IMAGING, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)4783999
• Email: techservices@LeicaBiosystems.com
• Phone: +1(866)4783999
• Email: techservices@LeicaBiosystems.com
• Phone: +1(866)4783999
• Email: techservices@LeicaBiosystems.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815477020068 [Primary]

FDA Product Code

• NQN: MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

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• 00815477020051 - eIHC IVD bundle CS2- 2500: 2018-03-29 Aperio ePathology IVD System CS2, includes; CS2 IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
• 00815477020068 - eIHC IVD bundle AT Turbo-2500: 2018-03-29Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
• 00815477020068 - eIHC IVD bundle AT Turbo-2500: 2018-03-29 Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500