COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 03155935018

GUDID 00875197000993

Roche Molecular Systems, Inc.

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197000993
• NIH Device Record Key: fc75b6c4-1ae5-448f-b364-f53b15145d76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COBAS AMPLICOR HIV-1 Monitor Test, version 1.5
• Version Model Number: 2
• Catalog Number: 03155935018
• 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: 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	00875197000993 [Primary]

FDA Product Code

• MTL: MONITOR,TEST,HIV-1

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: 2014-09-17

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