Identity
- Trade Name
- HemoTrol Duo FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, control FDA UDI
- Device Name
- HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin. FDA UDI
- Model / Reference
- Normal FDA UDI
- Description
- HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin. FDA UDI
Identifiers
- Catalog Number
- AN01624A02 FDA UDI
- Primary DI / UDI-DI
- 08718734961215 FDA UDI
- 510(k) Number
- K192842 FDA UDI
- FDA Product Code
- GGM FDA UDI
- GMDN Term
- Total haemoglobin (totHb) 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total haemoglobin (totHb) IVD, control
HemoTrol Duo by Eurotrol B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192842 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 |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
Sources (1)
- FDA UDI b3f7b57a-8c45-4df0-957b-60ec6c92b732 35 fields · synced May 30, 2026