Identity
- Trade Name
- FastPack® Total PSA Kit (50) FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 50 Test Non-Ported TPSA Immunoassay Kit FDA UDI
- Model / Reference
- TPSA Immunoassay FDA UDI
- Description
- 50 Test Non-Ported TPSA Immunoassay Kit FDA UDI
Identifiers
- Catalog Number
- 25000001 FDA UDI
- Primary DI / UDI-DI
- 10816467020010 FDA UDI
- 510(k) Number
- K003094 FDA UDI
- FDA Product Code
- LTJ FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
No
FDA UDI
Category: Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
FastPack® Total PSA Kit (50) by Qualigen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay.
- Elecsys total PSA — Roche Diagnostics Corp. · Class III
- Alinity — Abbott Ireland Diagnostics · Class III
- Elecsys total PSA — Roche Diagnostics Corp. · Class III
- Dimension Vista® System TPSA Flex® Reagent Cartridge — Siemens Healthcare Diagnostics · Class III
- Total PSA AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- Total PSA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class III
- Elecsys tPSA — Roche Diagnostics Corp. · Class III
Cleared under the same submission
K003094 also covers:
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 |
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Manufacturer
- Manufacturer
- Qualigen Inc.
Sources (1)
- FDA UDI 3978ff6f-d38b-4815-9a8c-2c9cd8abd968 37 fields · synced May 30, 2026