Elecsys AFP 09015124190

GUDID 07613336172025

Roche Diagnostics GmbH

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336172025
• NIH Device Record Key: 9d0df93c-f300-4d58-84e5-96fa94df0ffb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys AFP
• Version Model Number: 09015124190
• Catalog Number: 09015124190
• 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: false
• 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	07613336172025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220176

FDA Product Code

• LOJ: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Elecsys AFP]

• 07613336206164: 09015086160
• 07613336206157: 09015060160
• 07613336172025: 09015124190
• 07613336217146: 09731385190