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extendSURETM Haemoglobin A1c Lyophilised Controls
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref HB710SBAr
Identity
- Trade Name
- extendSURETM Haemoglobin A1c Lyophilised Controls EUDAMEDExtendSURE FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- extendSURETM Haemoglobin A1c Lyophilised Controls EUDAMEDThe lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls 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
- HB710SBAr EUDAMEDFDA UDI
- Description
- The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls 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
- 09421902348075 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09421902348075 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
extendSURETM Haemoglobin A1c Lyophilised 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-09421902348075 | 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 bf94c488-6ed9-4a76-8c01-d99aa813e279 61 fields · synced Jul 14, 2026
- FDA UDI 260db2c9-233b-4d75-bb93-d790f4251687 34 fields · synced May 30, 2026