Elecsys Testosterone II 08946370190

GUDID 07613336170571

Testosterone G2 Elecsys E2G 300 V2

Roche Diagnostics GmbH

Total testosterone IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336170571
• NIH Device Record Key: 75db47c8-5d77-4d0e-b1c3-2d15dc0d1a39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Testosterone II
• Version Model Number: 08946370190
• Catalog Number: 08946370190
• 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	07613336170571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211685

FDA Product Code

• CDZ: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

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: 2022-05-30
• Device Publish Date: 2022-05-21

On-Brand Devices [Elecsys Testosterone II]

• 04015630939312: 5200067160
• 07613336170571: Testosterone G2 Elecsys E2G 300 V2
• 07613336170557: Testosterone G2 Elecsys cobas e 100 V2
• 04015630939817: 07027915190