Identity
- Trade Name
- Maxim HIV-1 Urine Enzyme Immunoassay FDA UDI
- Generic Name
- HIV1 antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine. The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. Before a determination of HIV-1 status can be made, specimens that are repeatedly reactive using this test should be further tested only using the additional, more specific, Cambridge Biotech HIV-1 Urine Western Blot test. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine. The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. Before a determination of HIV-1 status can be made, specimens that are repeatedly reactive using this test should be further tested only using the additional, more specific, Cambridge Biotech HIV-1 Urine Western Blot test. FDA UDI
Identifiers
- Catalog Number
- 40000 FDA UDI
- Primary DI / UDI-DI
- 00864525000415 FDA UDI
- GMDN Term
- HIV1 antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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 antibody IVD, kit, enzyme immunoassay (EIA)
Maxim HIV-1 Urine Enzyme Immunoassay by Bluejay Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1 antibody IVD, kit, enzyme immunoassay (EIA).
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
- Bluejay Diagnostics, Inc.
Sources (1)
- FDA UDI f9684808-a945-4bb0-8488-2519ad6bd0d0 36 fields · synced May 31, 2026