Alere Determine™ HIV–1/2 Ag/Ab Combo Controls

GUDID 10811877010347

The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.

Alere Scarborough, Inc.

HIV1/HIV2 antigen/antibody IVD, control

• Primary Device ID: 10811877010347
• NIH Device Record Key: a1bd1a7b-2d2f-4d3f-8e2a-4129169846e2
• Commercial Distribution Discontinuation: 2024-03-23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Determine™ HIV–1/2 Ag/Ab Combo Controls
• Version Model Number: 7D2628
• Company DUNS: 154148498
• Company Name: Alere Scarborough, Inc.
• 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: true
• 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	10811877010347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP120037

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: 3
• Public Version Date: 2023-09-12
• Device Publish Date: 2017-05-11

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