cobas z 480 05200881001

GUDID 04015630929016

Roche Molecular Systems, Inc.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 04015630929016
• NIH Device Record Key: 37c13be6-1f8d-4d5a-a56e-ff629700e425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas z 480
• Version Model Number: 05200881001
• Catalog Number: 05200881001
• Company DUNS: 071674100
• Company Name: Roche Molecular Systems, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630929016 [Primary]

FDA Product Code

• MKZ: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-07-07
• Device Publish Date: 2014-09-15

Devices Manufactured by Roche Molecular Systems, Inc.

• 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
• 04015630929009 - cobas x 480 Analyzer: 2022-06-10
• 00875197006391 - cobas® HCV: 2021-12-22
• 00875197006407 - cobas® HIV-1: 2021-12-22