Identity
- Trade Name
- Express HIV-1 Test System FDA UDI
- Generic Name
- Capillary blood collection set, home-use FDA UDI
- Device Name
- The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing. FDA UDI
- Model / Reference
- 20 FDA UDI
- Description
- The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M769HIVEXPRESS201 FDA UDI
- FDA Product Code
- MVZ FDA UDI
- GMDN Term
- Capillary blood collection set, home-use FDA UDI
Classification
- Device Class
- Class III 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
Yes
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: Capillary blood collection set, home-use
Express HIV-1 Test System by Home Access Health Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BP950002 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Home Access Health Corp.
Sources (1)
- FDA UDI 74914157-a27c-4b4e-b8cd-f60b12da3d0a 35 fields · synced Jun 8, 2026