Factor V Leiden Kit 04618777001

GUDID 04038377021607

Roche Diagnostics GmbH

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• Primary Device ID: 04038377021607
• NIH Device Record Key: 29cbdb3f-2c18-45c9-8ec1-2ea168a96833
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Factor V Leiden Kit
• Version Model Number: 1
• Catalog Number: 04618777001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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	04038377021607 [Primary]

FDA Product Code

• NPQ: Test, Factor V Leiden 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: 2022-04-15
• Device Publish Date: 2016-09-23

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