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Fetal Hemoglobin
EUDAMEDFDA UDIClass A (EU MDR)
Ref 285D-1KTModel 285Model 285C-1KT and 285D-1KT
Identity
- Trade Name
- FETAL HEMOGLOBIN EUDAMEDFDA UDIFETAL HEMOGLOBIN Kit EUDAMED
- Generic Name
- Haemoglobin F (HbF) IVD, reagent FDA UDI
- Device Name
- FETAL HEMOGLOBIN EUDAMEDFetal Hemoglobin Kit 285 EUDAMEDFetal Hemoglobin Kit FDA UDI
- Model / Reference
- 285 EUDAMED285D-1KT EUDAMEDFDA UDI285C-1KT and 285D-1KT EUDAMED
- Description
- Fetal Hemoglobin Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04054839149108 EUDAMEDFDA UDI
- Basic UDI-DI
- 040618285K2 EUDAMED
- FDA Product Code
- GHQ FDA UDI
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
- GMDN Term
- Haemoglobin F (HbF) IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7455 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fetal Hemoglobin by Sigma-Aldrich Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 040618285K2 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED b22eca9f-e147-4b51-9eb1-23b629bd3d75 61 fields · synced Oct 6, 2026
- FDA UDI 710ba433-e7f2-4d00-8fb9-ae24186a950e 34 fields · synced May 30, 2026
- EUDAMED fd3c49d7-be49-4b6a-9a81-e048cf02345b 61 fields · synced Oct 6, 2026