Elecsys Anti-SARS-CoV 2 09203079190

GUDID 07613336179444

Roche Diagnostics GmbH

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336179444
• NIH Device Record Key: beacbf0a-e07e-4924-af11-df74bba8bf57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-SARS-CoV 2
• Version Model Number: 09203079190
• Catalog Number: 09203079190
• 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	07613336179444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250768

FDA Product Code

• QVP: SARS-CoV-2 serology test

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: 2025-07-30
• Device Publish Date: 2025-07-22

Devices Manufactured by Roche Diagnostics GmbH

• 07613336231357 - cobas i 601 SBL: 2025-08-18
• 07613336231388 - cobas pro i 601 BL: 2025-08-18
• 07613336222713 - navify: 2025-08-08
• 07613336228630 - HPLC Cartridge (iHPLC): 2025-08-08
• 07613336228647 - Rapid Cartridge B (iRapidB): 2025-08-08
• 07613336228654 - Rapid Cartridge C (iRapidC): 2025-08-08
• 07613336231364 - cobas i 601: 2025-08-08
• 04015630933457 - PreciControl Cortisol Urine: 2025-08-01