cobas Factor II and Factor V Test 07948352190

GUDID 00875197005998

Roche Molecular Systems, Inc.

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00875197005998
• NIH Device Record Key: d8becc8c-fb0b-40ea-99c8-af292e327364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas Factor II and Factor V Test
• Version Model Number: 07948352190
• Catalog Number: 07948352190
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00875197005998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172913

FDA Product Code

• NPR: TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-14

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