Alere Determine™ HIV–1/2 Ag/Ab Combo

GUDID 10811877010293

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.

Alere Scarborough, Inc.

HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: 10811877010293
• NIH Device Record Key: 7330ab83-eedb-4573-b748-ec2da60f8c1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Determine™ HIV–1/2 Ag/Ab Combo
• Version Model Number: 7D2648
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010293 [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: 2022-06-10
• Device Publish Date: 2017-05-11

On-Brand Devices [Alere Determine™ HIV–1/2 Ag/Ab Combo]

• 10811877010323: Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay
• 10811877010293: Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay