Tina-quant Myoglobin Gen.2 08252629190

GUDID 07613336147863

Roche Diagnostics GmbH

Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay Myoglobin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336147863
• NIH Device Record Key: a7289b38-000c-40de-8095-0017fe16aa59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tina-quant Myoglobin Gen.2
• Version Model Number: 08252629190
• Catalog Number: 08252629190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336147863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061683

FDA Product Code

• DDR: MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

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: 2020-08-31
• Device Publish Date: 2020-08-21

Devices Manufactured by Roche Diagnostics GmbH

• 07613336224816 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224823 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224830 - MTX Calibrator: 2024-04-02
• 07613336217689 - Elecsys ProBNP II: 2024-02-27
• 04015630929702 - cobas Elecsys AntiTPO: 2024-02-16
• 04015630939626 - Elecsys Anti-TPO: 2024-02-16
• 04015630899548 - Elecsys CalSet TUptake: 2024-02-05
• 04015630899579 - Elecsys Tuptake Assay: 2024-02-05