FDA UDI
In Commercial Distribution
🇺🇸 United States
Maxim HIV-1 Urine Enzyme Immunoassay
DI: 00864525000415
·
Model: 01
·
BLUEJAY DIAGNOSTICS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Maxim HIV-1 Urine Enzyme Immunoassay
- Primary DI
- 00864525000415
- Version / Model
- 01
- Catalog Number
- 40000
- Company Name
- BLUEJAY DIAGNOSTICS, INC.
- Labeler DUNS
- 080412181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-17
- Public Version
- 1
- Public Version Date
- 2019-07-25
- Public Version Status
- New
- Public Device Record Key
- f9684808-a945-4bb0-8488-2519ad6bd0d0
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48480 | HIV1 antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864525000415 | GS1 |
Customer Contacts
- Phone
- (844) 327-7078
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius