cobas® CMV Control Kit 09040919190

GUDID 00875197006490

Roche Molecular Systems, Inc.

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197006490
• NIH Device Record Key: 6fb759b9-4074-4b58-8df1-a1a4b3d73290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® CMV Control Kit
• Version Model Number: 09040919190
• Catalog Number: 09040919190
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00875197006490 [Primary]

FDA Product Code

• PAB: Cytomegalovirus (cmv) dna quantitative assay

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: 2021-12-22
• Device Publish Date: 2021-12-10

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