Identity
- Trade Name
- ExpertCor Routine FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- ExpertCor Routine plasma set consists of unassayed, ready-to-use human plasmas across reportable range of prothrombin time (PT), activated partial thromboplastin time (APTT), Fibrinogen and INR. The plasma set is intended for use in the quality control of coagulation assay performed on Coagulation Analyzers. FDA UDI
- Model / Reference
- 01306 FDA UDI
- Description
- ExpertCor Routine plasma set consists of unassayed, ready-to-use human plasmas across reportable range of prothrombin time (PT), activated partial thromboplastin time (APTT), Fibrinogen and INR. The plasma set is intended for use in the quality control of coagulation assay performed on Coagulation Analyzers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864608000226 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple coagulation factor IVD, control
ExpertCor Routine by Dsrv, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Dsrv, Inc.
Sources (1)
- FDA UDI 77f6612c-44d3-46f6-ab85-f40823ee9921 33 fields · synced May 30, 2026