Identity
- Trade Name
- total PSA Calset II FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
- Device Name
- Total PSA G2 CS Elecsys V2.1 FDA UDI
- Model / Reference
- 04485220160 FDA UDI
- Description
- Total PSA G2 CS Elecsys V2.1 FDA UDI
Identifiers
- Catalog Number
- 04485220160 FDA UDI
- Primary DI / UDI-DI
- 07613336154380 FDA UDI
- PMA Number
- P990056 FDA UDI
- FDA Product Code
- MTF FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- 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
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
Yes
FDA UDI
Category: Total prostate specific antigen (tPSA) IVD, calibrator
total PSA Calset II by Roche Diagnostics Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P990056 also covers:
- Elecsys Total PSA — Roche Diagnostics Corp.
- 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.
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 |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 8998114c-1109-40cc-b081-77d473ec2d3b 36 fields · synced May 30, 2026