Identity
- Trade Name
- ACCESS HIV Ag/Ab combo Calibrators FDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, calibrator FDA UDI
- Device Name
- The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human serum and plasma, using the DxI 9000 Access Immunoassay Analyzer. FDA UDI
- Model / Reference
- C39451 FDA UDI
- Description
- The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human serum and plasma, using the DxI 9000 Access Immunoassay Analyzer. FDA UDI
Identifiers
- Catalog Number
- C39451 FDA UDI
- Primary DI / UDI-DI
- 15099590745165 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- 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
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
Yes
FDA UDI
Category: HIV1/HIV2 antigen/antibody IVD, calibrator
ACCESS HIV Ag/Ab combo Calibrators by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 7ad74d73-3d46-455d-b753-fcf62293b6ad 34 fields · synced Jun 8, 2026