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ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
- Device Name
- Calibrator Q - 2 pack (PSA Cal) FDA UDI
- Model / Reference
- 10310295 FDA UDI
- Description
- Calibrator Q - 2 pack (PSA Cal) FDA UDI
Identifiers
- Catalog Number
- 118220 FDA UDI
- Primary DI / UDI-DI
- 00630414202938 FDA UDI
- PMA Number
- P950021 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
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, calibrator
ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total prostate specific antigen (tPSA) IVD, calibrator.
- total PSA CalSet II — Roche Diagnostics Corp. · Class III
- AIA-PACK PA CALBRATOR SET — Tosoh Corp. · Class II
- Alinity — Abbott Ireland Diagnostics · Class III
- Calibrator Kit - PSA — QUALIGEN INC. · Class II
- total PSA Calset II — Roche Diagnostics Corp. · Class III
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics · Class III
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics · Class III
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
- 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
- Atellica IM PSA MCM — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 352d5e6a-4782-4e2f-b717-eca77c496c29 37 fields · synced May 30, 2026