AcfS Library Robot 07759371001

GUDID 07613336172353

Roche Molecular Systems, Inc.

Pipetting system IVD

• Primary Device ID: 07613336172353
• NIH Device Record Key: cda5d9b2-b7d8-482c-ac1e-3db78e980f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcfS Library Robot
• Version Model Number: 07759371001
• Catalog Number: 07759371001
• Company DUNS: 117676383
• Company Name: Roche Molecular Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336172353 [Primary]

FDA Product Code

• JQW: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

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: 2025-02-07
• Device Publish Date: 2025-01-30

Devices Manufactured by Roche Molecular Systems, Inc.

• 07613336155790 - AcfS L and D Equipment Installation Bundle: 2025-02-07
• 07613336172353 - AcfS Library Robot: 2025-02-07
• 07613336172353 - AcfS Library Robot: 2025-02-07
• 07613336172360 - AcfS Detection Robot: 2025-02-07
• 00875197006896 - cobas HPV Positive Control Kit: 2024-06-14
• 00875197006889 - cobas HPV: 2024-06-13
• 04015630936540 - cobas p630 Pre-Analytical Pipettor: 2022-09-16
• 04015630936557 - DOCKING STATION SHORT: 2022-09-16
• 00875197006445 - cobas® NHP Negative Control Kit: 2022-08-09