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Determine™ HIV–1/2 Ag/Ab Combo

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
Determine™ HIV–1/2 Ag/Ab Combo FDA UDI
Generic Name
HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical FDA UDI
Device Name
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. FDA UDI
Model / Reference
7D2648 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00811877011101 FDA UDI
FDA Product Code
MZF FDA UDI
GMDN Term
HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3956 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Determine™ HIV–1/2 Ag/Ab Combo by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical.

Cleared under the same submission

BP120037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI ded26c83-d562-4cda-bb38-d4302441a19d 34 fields · synced May 29, 2026