Identity
- Trade Name
- Atellica IM Calibrator Y FDA UDI
- Generic Name
- Complexed prostate specific antigen (cPSA) IVD, calibrator FDA UDI
- Device Name
- Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL FDA UDI
- Model / Reference
- 10995520 FDA UDI
- Description
- Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL FDA UDI
Identifiers
- Catalog Number
- 10995520 FDA UDI
- Primary DI / UDI-DI
- 00630414598475 FDA UDI
- PMA Number
- P990055 FDA UDI
- FDA Product Code
- NAF FDA UDI
- GMDN Term
- Complexed prostate specific antigen (cPSA) 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
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: Complexed prostate specific antigen (cPSA) IVD, calibrator
Atellica IM Calibrator Y by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Complexed prostate specific antigen (cPSA) IVD, calibrator.
Cleared under the same submission
P990055 also covers:
- ADVIA Centaur® Systems, ACS 180® Systems cPSA MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems cPSA 1, 2, 3 QC — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y — Siemens Healthcare Diagnostics
- ADVIA Centaur® cPSA PRE — Siemens Healthcare Diagnostics
- Atellica IM cPSA — Siemens Healthcare Diagnostics
- Atellica IM cPSA MCM — Siemens Healthcare Diagnostics
- Atellica IM cPSA PRE — Siemens Healthcare Diagnostics
- Atellica IM cPSA QC — 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 24344c68-261a-4e5c-b78a-999c8b45119f 37 fields · synced Jun 6, 2026