cobas¿ HCV Quantitative nucleic acid test for use on the cobas¿ 68008800 System 06998798190

GUDID 00875197004694

Roche Diagnostics GmbH

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197004694
• NIH Device Record Key: b2a92d34-9a12-4f44-ad96-5d87d11083c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas¿ HCV Quantitative nucleic acid test for use on the cobas¿ 68008800 System
• Version Model Number: 6998798190
• Catalog Number: 06998798190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: true
• 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	00875197004694 [Primary]

FDA Product Code

• MZP: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-12-04

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