Identity
- Trade Name
- Alere Determine HIV-1/2 Ag/Ab Combo Controls FDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, control FDA UDI
- Device Name
- Contents HIV-1 Reactive Control, 1.5 mL HIV-2 Reactive Control, 1.5 mL P24 Antigen Control, 1.5 mL HIV Nonreactive Control, 1.5 mL FDA UDI
- Model / Reference
- Alere Determine HIV-1/2 Ag/Ab Combo Cont FDA UDI
- Description
- Contents HIV-1 Reactive Control, 1.5 mL HIV-2 Reactive Control, 1.5 mL P24 Antigen Control, 1.5 mL HIV Nonreactive Control, 1.5 mL FDA UDI
Identifiers
- Catalog Number
- 7D2628 FDA UDI
- Primary DI / UDI-DI
- 07290015003759 FDA UDI
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Classification
- 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
No
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, control
Alere Determine HIV-1/2 Ag/Ab Combo Controls by Orgenics, Ltd. — 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
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Orgenics, Ltd.
Sources (1)
- FDA UDI d433d2b3-af8a-44c7-a039-d7c6c5b4f5be 36 fields · synced May 30, 2026