Elecsys BRAHMS PCT 10456299190

GUDID 07613336236499

Roche Diagnostics GmbH

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336236499
• NIH Device Record Key: 2ea9e43f-e592-4fe8-a69e-66183d6835ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys BRAHMS PCT
• Version Model Number: 10456299190
• Catalog Number: 10456299190
• 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	07613336236499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192815

FDA Product Code

• PRI: Procalcitonin assay

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: 2026-02-27
• Device Publish Date: 2026-02-19

On-Brand Devices [Elecsys BRAHMS PCT]

• 07613336166642: 08828679190
• 07613336166635: 08828644190
• 04015630940073: 07301715190
• 04015630939114: 5056888200
• 07613336236499: 10456299190