cobas® EBV 08688206190

GUDID 00875197006261

Roche Molecular Systems, Inc.

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197006261
• NIH Device Record Key: 8c44499e-fc65-4ef8-84b2-94d5fd4fe492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas® EBV
• Version Model Number: 08688206190
• Catalog Number: 08688206190
• 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	00875197006261 [Primary]

FDA Product Code

• QLX: Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA

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: 2020-09-18
• Device Publish Date: 2020-09-10

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• 00875197006407 - cobas® HIV-1: 2021-12-22
• 00875197006414 - cobas® HBV: 2021-12-22
• 00875197006421 - cobas® CMV: 2021-12-22