Elecsys HIV combi PT 05390095160

GUDID 04015630942497

HIV combi PT Elecsys cobas e 100

Roche Diagnostics GmbH

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630942497
• NIH Device Record Key: 3d93edcc-65e8-4e48-b552-088b8be0dd82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys HIV combi PT
• Version Model Number: 05390095160
• Catalog Number: 05390095160
• 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	04015630942497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP160050

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-10
• Device Publish Date: 2017-07-31

On-Brand Devices [Elecsys HIV combi PT]

• 07613336170212: 08924180160
• 07613336170182: 08924163160
• 04015630942497: HIV combi PT Elecsys cobas e 100