Elecsys Testosterone II 07027915190

GUDID 04015630939817

Roche Diagnostics GmbH

Total testosterone IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630939817
• NIH Device Record Key: 44bcb22e-095b-4f53-aa1b-3f0adf806bf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Testosterone II
• Version Model Number: 07027915190
• Catalog Number: 07027915190
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630939817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093421

FDA Product Code

• CDZ: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2017-04-21

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