cobas® EZH2 Mutation Test 07258321190

GUDID 00875197005592

Roche Molecular Systems, Inc.

Enhancer of zeste homolog 2 (EZH2) gene mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005592
• NIH Device Record Key: 1caf27c9-7d57-4d3b-8632-af46f385e636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® EZH2 Mutation Test
• Version Model Number: 7258321190
• Catalog Number: 07258321190
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00875197005592 [Primary]

FDA Product Code

• OWD: Somatic gene mutation detection system

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: 2020-08-10
• Device Publish Date: 2020-08-01

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