Elecsys Chagas 09015582162

GUDID 07613336228494

Roche Diagnostics GmbH

Trypanosoma cruzi total antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336228494
• NIH Device Record Key: f7e0aec0-1707-4339-a138-771f090e655e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Chagas
• Version Model Number: 09015582162
• Catalog Number: 09015582162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 9
• 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	07613336183113 [Primary]
GS1	07613336228494 [Unit of Use]

FDA Product Code

• QHM: Serology tests used for infectious disease screening of blood and plasma donations

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: 2025-02-26
• Device Publish Date: 2025-02-18

Devices Manufactured by Roche Diagnostics GmbH

• 04015630924288 - sFlT-1 CalSet: 2025-04-15
• 04015630925407 - CalSet PlGF: 2025-04-15
• 07613336172094 - Elecsys sFlT-1: 2025-04-15
• 07613336172124 - Elecsys PlGF: 2025-04-15
• 07613336220108 - PreciControl Rubella IgM: 2025-04-15
• 07613336230671 - Elecsys sFlT-1: 2025-04-15
• 07613336230756 - Elecsys PlGF: 2025-04-15
• 07613336223321 - Kidney KFRE Algorithm: 2025-04-08