Identity
- Trade Name
- PATHFAST D-Dimer FDA UDI
- Generic Name
- D-dimer IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987595301537 FDA UDI
- 510(k) Number
- K072288 FDA UDI
- FDA Product Code
- GHH FDA UDI
- GMDN Term
- D-dimer IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7320 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
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: D-dimer IVD, kit, chemiluminescent immunoassay
PATHFAST D-Dimer by Phc Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phc Corporation
Sources (1)
- FDA UDI d1505769-b534-4fea-bd7a-29d8fba72643 34 fields · synced Jun 8, 2026