Identity
- Trade Name
- CueSee® Coag FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. FDA UDI
- Model / Reference
- 3 FDA UDI
- Description
- CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals. FDA UDI
Identifiers
- Catalog Number
- 340.003.005 FDA UDI
- Primary DI / UDI-DI
- 08718734962748 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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Combination Product
No
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HCT/P
No
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Premarket Exempt
Yes
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Category: Multiple coagulation factor IVD, control
CueSee® Coag by Eurotrol B.V. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
Sources (1)
- FDA UDI 28296eb8-8938-4919-bcfd-ede8c0689067 34 fields · synced May 29, 2026