Identity
- Trade Name
- Dimension® Flex Reagent Cartridge HB1C FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator FDA UDI
- Model / Reference
- 10483822 FDA UDI
- Description
- Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator FDA UDI
Identifiers
- Catalog Number
- DF105A FDA UDI
- Primary DI / UDI-DI
- 00842768032615 FDA UDI
- 510(k) Number
- K102510 FDA UDI
- FDA Product Code
- JJX FDA UDILCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI864.7470 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimension® Flex Reagent Cartridge HB1C by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI fbdf08fc-69a4-436f-8e38-bac18ce5124b 38 fields · synced Jun 1, 2026