CalSet PTH STAT 08243930190

GUDID 07613336147696

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, calibrator

• Primary Device ID: 07613336147696
• NIH Device Record Key: 3ca9e727-72a9-4e57-9f6f-5767aadb581c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CalSet PTH STAT
• Version Model Number: 08243930190
• Catalog Number: 08243930190
• 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: 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	07613336147696 [Primary]

FDA Product Code

• JIT: Calibrator, secondary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-03-21

On-Brand Devices [CalSet PTH STAT]

• 07613336147696: 08243930190
• 07613336173497: 08928509190