Elecsys PTH 09744436190

GUDID 07613336217542

E2G 100 count

Roche Diagnostics GmbH

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336217542
• NIH Device Record Key: 3f94010e-5926-47a3-805f-c2cbe4cc05aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys PTH
• Version Model Number: 09744436190
• Catalog Number: 09744436190
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336217542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231927

FDA Product Code

• CEW: RADIOIMMUNOASSAY, PARATHYROID 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: 2024-08-07
• Device Publish Date: 2024-07-30

On-Brand Devices [Elecsys PTH]

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