Identity
- Trade Name
- AIA-PACK PA CALBRATOR SET FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
- Model / Reference
- n/a FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211988 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
Aia-Pack Pa Calbrator Set by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total prostate specific antigen (tPSA) IVD, calibrator.
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics · Class III
- total PSA CalSet II — Roche Diagnostics Corp. · Class III
- Atellica IM Calibrator Q — Siemens Healthcare Diagnostics · Class III
- Alinity — Abbott Ireland Diagnostics · Class III
- ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics · Class III
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics · Class III
- Calibrator Kit - PSA — QUALIGEN INC. · Class II
- total PSA Calset II — Roche Diagnostics Corp. · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tosoh Corp.
Sources (1)
- FDA UDI cb1b9f79-6eb2-46b3-ab5a-028ba9bdae27 34 fields · synced Jun 1, 2026