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extendSURE™ HbA1c Liquid Controls
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref B12397
Identity
- Trade Name
- extendSURE™ HbA1c Liquid Controls EUDAMEDExtendSURE FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- extendSURE™ HbA1c Liquid Controls EUDAMEDThe liquid Hemoglobin A1c Control kit contains 12 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
- B12397 EUDAMEDFDA UDI
- Description
- The liquid Hemoglobin A1c Control kit contains 12 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
- 09421902348099 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09421902348099 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, control 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
extendSURE™ HbA1c Liquid 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-09421902348099 | 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 657c3b6c-928a-4647-98d1-5075a78fb703 61 fields · synced Aug 3, 2026
- FDA UDI d0d5d5ee-c11a-4725-af1e-dea426815bb8 34 fields · synced May 30, 2026