Identity
- Trade Name
- Atellica IM PSA MCM FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, control FDA UDI
- Device Name
- Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995664 FDA UDI
- Description
- Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995664 FDA UDI
- Primary DI / UDI-DI
- 00630414599823 FDA UDI
- PMA Number
- P950021 FDA UDI
- FDA Product Code
- LTJ FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
No
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, control
Atellica IM PSA MCM by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total prostate specific antigen (tPSA) IVD, control.
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Cleared under the same submission
P950021 also covers:
- ADVIA Centaur® PSA — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS 180® Systems PSA MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics
- Atellica IM PSA — Siemens Healthcare Diagnostics
- Atellica IM PSA — Siemens Healthcare Diagnostics
- Atellica IM PSA — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2d895b50-ddcf-4687-a0ff-601c54b9da08 37 fields · synced May 30, 2026