Elecsys TSH 08429324160

GUDID 07613336157626

Roche Diagnostics GmbH

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336157626
• NIH Device Record Key: 168ef6bc-d8c3-4aef-bf95-38cad5505012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys TSH
• Version Model Number: 08429324160
• Catalog Number: 08429324160
• 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	07613336157626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190773

FDA Product Code

• JLW: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [Elecsys TSH]

• 07613336157633: 08443432190
• 07613336157626: 08429324160
• 07613336193693: 08443432214