Identity
- Trade Name
- VALIDATE FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, control FDA UDI
- Device Name
- VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: total prostate-specific antigen (Total PSA) and free prostate-specific antigen (FPSA). FDA UDI
- Model / Reference
- 406ab FDA UDI
- Description
- VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: total prostate-specific antigen (Total PSA) and free prostate-specific antigen (FPSA). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135631 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, controlFree (unbound) prostate specific antigen (fPSA) IVD, control
Validate by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free (unbound) prostate specific antigen (fPSA) IVD, control.
- Alinity — Abbott Ireland Diagnostics · Class III
- Elecsys free PSA — Roche Diagnostics Corp. · Class III
- ARCHITECT — Abbott Ireland Diagnostics · Class III
- Elecsys free PSA — Roche Diagnostics Corp. · Class III
- Elecsys free PSA — Roche Diagnostics Corp. · Class III
- Elecsys free PSA — Roche Diagnostics Corp. · Class III
- IMMULITE® Systems fPS Calibration Verification Material Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- PSA Control Slides — BIO SB, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI 5cea3f74-a48b-4839-b732-f58c518028c2 35 fields · synced Jun 9, 2026