Identity
- Trade Name
- TOSOH FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert FDA UDI
- Model / Reference
- 220232 FDA UDI
- Description
- Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421902348068 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatographyGlucose/haemoglobin (Hb) IVD, control
Tosoh by Canterbury Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Canterbury Scientific , Ltd.
Sources (1)
- FDA UDI a3f9d870-dff4-4ff4-b876-08affc5dca30 34 fields · synced May 30, 2026