Atellica IM Calibrator Q
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- Atellica IM Calibrator Q (CAL Q) EUDAMEDAtellica IM Calibrator Q FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_REAG_CAL Q EUDAMEDCalibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL FDA UDI
- Model / Reference
- 10995517 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_REAG_CAL Q EUDAMED
- Description
- Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL FDA UDI
Identifiers
- Catalog Number
- 10995517 FDA UDI
- Primary DI / UDI-DI
- 00630414598444 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901832VX EUDAMED
- Unit of Use DI
- 00630414190884 EUDAMED
- PMA Number
- P950021 FDA UDI
- FDA Product Code
- MTF FDA UDI
- EMDN Code
- W0102152205 TUMOUR MARKER STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Total prostate specific antigen (tPSA) IVD, calibrator
Atellica IM Calibrator Q by Siemens Healthcare Diagnostics — Class III — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- ADVIA Centaur® Systems. ACS:180® Systems 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
- ADVIA Centaur® Systems. ACS:180® Systems 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 (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 5cb17a82-3530-4a37-809d-8467521156fd 37 fields · synced Aug 1, 2026
- EUDAMED 8f6f6c23-a189-44cf-b19a-44f4b931550c 61 fields · synced Aug 1, 2026