cobas Synergy

GUDID 05060496770004

cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of sa

STRATEC BIOMEDICAL UK LIMITED

Blood bank information system application software

• Primary Device ID: 05060496770004
• NIH Device Record Key: 6558aa7d-50fe-4f87-92f4-439c9e507374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas Synergy
• Version Model Number: 1
• Company DUNS: 502054265
• Company Name: STRATEC BIOMEDICAL UK LIMITED
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060496770004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK160113

FDA Product Code

• PQQ: Data Acquisition Software

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: 2018-10-19
• Device Publish Date: 2018-09-18

Devices Manufactured by STRATEC BIOMEDICAL UK LIMITED

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• 05060496770011 - Procleix NAT Manager: 2018-11-02 Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which a
• 05060496770028 - ORTHO CONNECT: 2018-11-02 ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track
• 05060496770004 - cobas Synergy: 2018-10-19cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of sa
• 05060496770004 - cobas Synergy: 2018-10-19 cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample materi