Elecsys Anti-TSHR 08496633190

GUDID 07613336160329

Roche Diagnostics GmbH

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336160329
• NIH Device Record Key: b469d51d-b34c-4d04-8c22-ed394817ecd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-TSHR
• Version Model Number: 08496633190
• Catalog Number: 08496633190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336160329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193313

FDA Product Code

• JZO: SYSTEM, TEST, THYROID AUTOANTIBODY

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: 2020-04-22
• Device Publish Date: 2020-04-14

On-Brand Devices [Elecsys Anti-TSHR]

• 07613336160329: 08496633190
• 07613336160305: 08496609190