Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Free (unbound) prostate specific antigen (fPSA) IVD, calibrator FDA UDI
- Device Name
- ARCHITECT Free PSA Calibrators FDA UDI
- Model / Reference
- 6C07-01 FDA UDI
- Description
- ARCHITECT Free PSA Calibrators FDA UDI
Identifiers
- Catalog Number
- 06C0701 FDA UDI
- Primary DI / UDI-DI
- 00380740009007 FDA UDI
- FDA Product Code
- MTG FDA UDI
- GMDN Term
- Free (unbound) prostate specific antigen (fPSA) 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Free (unbound) prostate specific antigen (fPSA) IVD, calibrator
Architect by Abbott Ireland Diagnostics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free (unbound) prostate specific antigen (fPSA) IVD, calibrator.
- free PSA CalSet — Roche Diagnostics Corp. · Class III
- Elecsys Free PSA CalSet — Roche Diagnostics Corp. · Class III
- free PSA Calset — Roche Diagnostics Corp. · Class III
- Alinity — Abbott Ireland Diagnostics · 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 III | Pending data |
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Manufacturer
- Manufacturer
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI d239ef75-9966-4df2-8f4e-615b3bd1f10a 36 fields · synced May 30, 2026