Elecsys SHBG 3052001160

GUDID 04015630939305

Roche Diagnostics GmbH

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630939305
• NIH Device Record Key: 15e7fb66-6978-40c0-943d-72458d3b950a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys SHBG
• Version Model Number: 3052001160
• Catalog Number: 3052001160
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630939305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102814

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: 2021-01-28
• Device Publish Date: 2021-01-20

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