Identity
- Trade Name
- PF4 Enhanced® FDA UDI
- Generic Name
- Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy. FDA UDI
- Model / Reference
- X-HAT45 FDA UDI
- Description
- PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy. FDA UDI
Identifiers
- Catalog Number
- X-HAT45 FDA UDI
- Primary DI / UDI-DI
- 10888234500032 FDA UDI
- FDA Product Code
- LCO FDA UDI
- GMDN Term
- Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7695 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: Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)
PF4 Enhanced® by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Platelet factor 4 IVD, kit, enzyme immunoassay (EIA).
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- PF4 Enhanced® — Immucor GTI Diagnostics, Inc. · Class II
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- PF4 IgG — Immucor GTI Diagnostics, Inc. · Class II
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
- Immucor GTI Diagnostics, Inc.
Sources (1)
- FDA UDI da15e5c3-ccc4-4b26-befe-7ca90d42eb31 36 fields · synced Jun 1, 2026