Identity
- Trade Name
- Access Hyritech free PSA Calibrators FDA UDI
- Generic Name
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems. FDA UDI
- Model / Reference
- 37215 FDA UDI
- Description
- The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems. FDA UDI
Identifiers
- Catalog Number
- 37215 FDA UDI
- Primary DI / UDI-DI
- H628372151 FDA UDI
- FDA Product Code
- MTG FDA UDI
- GMDN Term
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay 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
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
Yes
FDA UDI
Category: Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Access Hyritech free PSA Calibrators by Beckman Coulter, Inc. — Class III — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay.
- Alinity — Abbott Ireland Diagnostics · Class III
- ARCHITECT — Abbott Ireland Diagnostics · Class III
- IMMULITE®/IMMULITE®1000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Dimension Vista® System FPSA Flex® Reagent Cartridge — Siemens Healthcare Diagnostics · Class III
- Alinity — Abbott Ireland Diagnostics · Class III
- IMMULITE® 2000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Access Hybritech free PSA — Beckman Coulter, Inc. · Class III
- Access Hybritech p2PSA Calibrators — Beckman Coulter, Inc. · Class III
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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
- Beckman Coulter, Inc.
Sources (2)
- FDA UDI 0833a800-1b13-4558-9cd7-790722675ae8 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026