Identity
- Trade Name
- Triage FDA UDI
- Generic Name
- D-dimer IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Triage D-Dimer Test FDA UDI
- Model / Reference
- 98100 FDA UDI
- Description
- Triage D-Dimer Test FDA UDI
Identifiers
- Catalog Number
- 98100 FDA UDI
- Primary DI / UDI-DI
- 30014613338000 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, kit, fluorescent 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: D-dimer IVD, kit, fluorescent immunoassay
Triage by Quidel Cardiovascular Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as D-dimer IVD, kit, fluorescent immunoassay.
- Stratus® CS Acute Care™ DDMR DilPak — Siemens Healthcare Diagnostics · Class II
- Acute Care™ D-DIMER CalPak — Siemens Healthcare Diagnostics · Class II
- Fluoro-CheckTM D-Dimer — Nano-Ditech Corporation · Class II
- Stratus® CS Acute Care™ DDMR TestPak — Siemens Healthcare Diagnostics · Class II
- Triage — Quidel Cardiovascular 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quidel Cardiovascular Inc.
Sources (1)
- FDA UDI 5d26b8e4-5253-4f69-bd1e-fd44f8c99b2f 35 fields · synced May 30, 2026