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

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name: Determine™ HIV–1/2 Ag/Ab Combo Controls FDA UDI
Generic Name: HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Device Name: The Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine™ HIV-1/2 Ag/Ab Combo Assay only. FDA UDI
Model / Reference: 7D2628 FDA UDI
Description: The Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine™ HIV-1/2 Ag/Ab Combo Assay only. FDA UDI

Identifiers

Primary DI / UDI-DI: 00811877011125 FDA UDI
FDA Product Code: MZF FDA UDI
GMDN Term: HIV1/HIV2 antigen/antibody IVD, control 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: HIV1/HIV2 antigen/antibody IVD, control

Determine™ HIV–1/2 Ag/Ab Combo Controls 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, control.

PreciControl HIV Gen II — Roche Diagnostics Corp. · Class I
PreciControl HIV; HIV-2 + GrpO — Roche Diagnostics Corp. · Class I
GS — Bio-Rad Laboratories · Class II
LIAISON XL MUREX Control HIV Ab/Ag HT — Diasorin S.P.A
PreciControl Release HIV Gen II — Roche Diagnostics Corp. · U
Alinity — Abbott
Alinity — Abbott
ACCESS HIV Ag/Ab combo QC — Beckman Coulter, Inc. · Class I

Cleared under the same submission

BP120037 also covers:

Determine™ HIV–1/2 Ag/Ab Combo — Alere Scarborough, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Alere Scarborough, Inc.

Sources (1)

FDA UDI 2e13056b-044d-47a7-8bbc-7b7af2a0d54a 34 fields · synced May 30, 2026