CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH

GUDID 00849832013327

CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH

Leica Biosystems Richmond, Inc.

Cell morphology analyser IVD, automated

• Primary Device ID: 00849832013327
• NIH Device Record Key: 5e2a561d-7c80-4de3-ac17-7065412c7945
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH
• Version Model Number: 23GSL120KFXROB
• Company DUNS: 082930884
• Company Name: Leica Biosystems Richmond, 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: false
• Manufacturing Date: false
• 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(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com

Device Dimensions

• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849832013327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042542

FDA Product Code

• JOY: DEVICE, AUTOMATED CELL-LOCATING

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-23
• Device Publish Date: 2018-06-20

Devices Manufactured by Leica Biosystems Richmond, Inc.

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• 00849832020615 - Leica Biosystems: 2025-01-06 IP III Cassette with lid, stacked, Aqua
• 00849832022077 - Leica Biosystems: 2025-01-06 IP III Cassette with lid, Taped, Lilac
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• 00849832022275 - Leica Biosystems: 2025-01-06 IP III Biopsy with closed lid, Taped, White
• 00849832027157 - Leica Biosystems: 2025-01-06 IP III Biopsy with closed lid, Taped, Pink