Elecsys HTLV-I/II 09015272162

GUDID 07613336228470

Roche Diagnostics GmbH

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336228470
• NIH Device Record Key: 9a9ff632-fa9d-46a5-b4f4-5314786771f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HTLV-I/II
• Version Model Number: 09015272162
• Catalog Number: 09015272162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 20
• 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	07613336183090 [Primary]
GS1	07613336228470 [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

• 07613336183045 - PreciControl Release HIV Gen II: 2025-02-27
• 07613336228487 - Elecsys Anti-HBc II: 2025-02-27
• 07613336228500 - Elecsys HIV Duo: 2025-02-27
• 07613336183212 - PreciControl HIV Gen II: 2025-02-27
• 07613336183229 - PreciControl HIV; HIV-2+GrpO: 2025-02-27
• 07613336182970 - PreciControl Release Anti-HCV: 2025-02-26
• 07613336183014 - PreciControl Release HTLV: 2025-02-26
• 07613336183021 - PreciControl Release Anti-HBc II: 2025-02-26