Elecsys PTH 07251068190

GUDID 04015630939787

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630939787
• NIH Device Record Key: e9b172f3-b14a-4eb5-b7cd-349baed4ede4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys PTH
• Version Model Number: 07251068190
• Catalog Number: 07251068190
• 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	04015630939787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070709

FDA Product Code

• CEW: RADIOIMMUNOASSAY, PARATHYROID HORMONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-04-21

On-Brand Devices [Elecsys PTH]

• 04015630939787: 07251068190
• 07613336224922: 08928380160
• 07613336217542: E2G 100 count
• 07613336170304: E2G 300 count