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
- 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. FDA UDI
- Model / Reference
- 7D2628 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010347 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
- Not 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
Alere Determine™ HIV–1/2 Ag/Ab Combo Controls by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI a1bd1a7b-2d2f-4d3f-8e2a-4129169846e2 35 fields · synced May 30, 2026