Identity
- Trade Name
- CueSee® CO-OX FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, control FDA UDI
- Device Name
- CueSee® CO-OX S3B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory). FDA UDI
- Model / Reference
- S3B FDA UDI
- Description
- CueSee® CO-OX S3B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory). FDA UDI
Identifiers
- Catalog Number
- AN01718A02 FDA UDI
- Primary DI / UDI-DI
- 08718734961574 FDA UDI
- FDA Product Code
- GGM FDA UDI
- GMDN Term
- Multiple haemoglobin subtype IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple haemoglobin subtype IVD, control
CueSee® CO-OX 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 c80e0cd0-1c66-4b3e-9e76-c718a169888e 34 fields · synced May 30, 2026