cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems 07460066190

GUDID 00875197005776

Roche Molecular Systems, Inc.

Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005776
• NIH Device Record Key: 48ebbe30-114c-4eab-91f4-077a3aed4ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
• Version Model Number: 07460066190
• Catalog Number: 07460066190
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197005776 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-05-28
• Device Publish Date: 2018-04-26

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