Identity
- Trade Name
- Elecsys Total PSA FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 09744860190 FDA UDI
Identifiers
- Catalog Number
- 09744860190 FDA UDI
- Primary DI / UDI-DI
- 07613336217665 FDA UDI
- PMA Number
- P990056 FDA UDI
- FDA Product Code
- MTF FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class III 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: Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Elecsys Total PSA by Roche Diagnostics Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay.
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- ARCHITECT — Abbott Ireland Diagnostics · Class I
Cleared under the same submission
P990056 also covers:
- Elecsys tPSA — Roche Diagnostics Corp.
- Elecsys tPSA — Roche Diagnostics Corp.
- Elecsys total PSA — Roche Diagnostics Corp.
- Elecsys total PSA — Roche Diagnostics Corp.
- Elecsys total PSA — Roche Diagnostics Corp.
- Elecsys total PSA — Roche Diagnostics Corp.
- total PSA CalSet II — Roche Diagnostics Corp.
- total PSA Calset II — Roche Diagnostics Corp.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 7dcee2fe-43ae-4b06-b65a-d11257592017 34 fields · synced Jun 6, 2026