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extendSURE™ Haemoglobin F and A2 Controls
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref HB110SSBAr
Identity
- Trade Name
- extendSURE™ Haemoglobin F and A2 Controls EUDAMEDExtendSURE FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, control FDA UDI
- Device Name
- extendSURE™ Haemoglobin F and A2 Controls EUDAMEDThe lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 vials each of level 1 and level 2 control which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. FDA UDI
- Model / Reference
- HB110SSBAr EUDAMEDFDA UDI
- Description
- The lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 vials each of level 1 and level 2 control which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421902348037 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09421902348037 EUDAMED
- FDA Product Code
- JCM FDA UDI
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
- GMDN Term
- Multiple haemoglobin subtype IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7415 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
extendSURE™ Haemoglobin F and A2 Controls by Canterbury Scientific Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-09421902348037 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Canterbury Scientific Limited
- EUDAMED SRN
- NZ-MF-000001778
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dd5f0c62-a93e-4342-8206-a7098dba4933 61 fields · synced Jun 19, 2026
- FDA UDI 40f67261-c7d7-4e02-accb-352802771965 34 fields · synced May 30, 2026