Identity
- Trade Name
- Elecsys HIV combi PT FDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 08924180160 FDA UDI
Identifiers
- Catalog Number
- 08924180160 FDA UDI
- Primary DI / UDI-DI
- 07613336170212 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 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
No
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/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Elecsys HIV combi PT by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay.
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- VITROS — Ortho-Clinical Diagnostics · Class II
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- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott · Class II
- LIAISON XL MUREX HIV Ab/Ag HT — Diasorin S.P.A
Cleared under the same submission
BP160050 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 7699c998-47d7-4c25-9f30-a13b50b66aa3 34 fields · synced Jun 8, 2026