Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Alinity i Free PSA Reagent Kit 200 Tests FDA UDI
- Model / Reference
- 07P9321 FDA UDI
- Description
- Alinity i Free PSA Reagent Kit 200 Tests FDA UDI
Identifiers
- Catalog Number
- 07P9321 FDA UDI
- Primary DI / UDI-DI
- 00380740158330 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
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, kit, chemiluminescent immunoassay
Alinity 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, kit, chemiluminescent immunoassay.
- Access Hybritech free PSA — Beckman Coulter, Inc. · Class III
- Access Hybritech p2PSA Calibrators — Beckman Coulter, Inc. · Class III
- Access Hyritech free PSA Calibrators — Beckman Coulter, Inc. · Class III
- IMMULITE®/IMMULITE®1000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Access Hybritech p2PSA — Beckman Coulter, Inc. · Class III
- Dimension Vista® System FPSA Flex® Reagent Cartridge — Siemens Healthcare Diagnostics · Class III
- IMMULITE® 2000 Systems fPS Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- ARCHITECT — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 8a0fd03f-7529-4ac1-8511-ea8430b1a69f 36 fields · synced May 30, 2026