← Back to catalogue
Cambridge Biotech HIV-1 Urine Western Blot Kit
FDA UDIIdentity
- Trade Name
- Cambridge Biotech HIV-1 Urine Western Blot Kit FDA UDI
- Generic Name
- HIV1 antibody IVD, kit, immunoblot FDA UDI
- Device Name
- The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine specimens. This more specific assay is used as a supplemental test with urine specimens that tested repeatedly reactive using a screening procedure (Urine EIA Kit). The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine specimens. This more specific assay is used as a supplemental test with urine specimens that tested repeatedly reactive using a screening procedure (Urine EIA Kit). The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. FDA UDI
Identifiers
- Catalog Number
- 45000 FDA UDI
- Primary DI / UDI-DI
- 00864525000422 FDA UDI
- GMDN Term
- HIV1 antibody IVD, kit, immunoblot 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 antibody IVD, kit, immunoblot
Cambridge Biotech HIV-1 Urine Western Blot Kit by Bluejay Diagnostics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1 antibody IVD, kit, immunoblot.
- GS — Bio-Rad Laboratories · N
- GS — Bio-Rad Laboratories · N
- GS — Bio-Rad Laboratories · N
- GS — Bio-Rad Laboratories · N
- GS — Bio-Rad Laboratories · N
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bluejay Diagnostics, Inc.
Sources (1)
- FDA UDI b0001861-1b6d-4921-96f2-beb233c73e36 35 fields · synced Jun 6, 2026