CalSet PTH STAT 08928509190

GUDID 07613336173497

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, calibrator

• Primary Device ID: 07613336173497
• NIH Device Record Key: a50889b2-8be8-4777-bfe1-8372e8e6be4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CalSet PTH STAT
• Version Model Number: 08928509190
• Catalog Number: 08928509190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336173497 [Primary]

FDA Product Code

• JJX: Single (specified) analyte controls (assayed and unassayed)

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: 2024-08-07
• Device Publish Date: 2024-07-30

On-Brand Devices [CalSet PTH STAT]

• 07613336147696: 08243930190
• 07613336173497: 08928509190