Identity
- Trade Name
- Thromboplastin-LI Reagent Kit FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, reagent FDA UDI
- Model / Reference
- 5248 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52552480 FDA UDI
- 510(k) Number
- K040296 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Prothrombin time (PT) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7750 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
No
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: Prothrombin time (PT) IVD, reagent
Thromboplastin-LI Reagent Kit by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prothrombin time (PT) IVD, reagent.
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Dade Innovin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Dade® Innovin® — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Dade® Innovin® — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- QuikCoag PT-HS — Biomedica Diagnostics Inc · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- IDG/Sanzay — IDG/SANZAY Corporation · Class II
- Xprecia Prime™ PT/INR Test Strips — UNIVERSAL BIOSENSORS PTY LTD · Class II
Cleared under the same submission
K040296 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 8c6cbf0e-58bb-4497-be3c-c0a111ef09ca 34 fields · synced Jun 9, 2026