Identity
- Trade Name
- Dimension Clinical Chemistry System A1C Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- A1C Reagent Kit FDA UDI
- Model / Reference
- 10720883 FDA UDI
- Description
- A1C Reagent Kit FDA UDI
Identifiers
- Catalog Number
- DF105B FDA UDI
- Primary DI / UDI-DI
- 00630414006659 FDA UDI
- 510(k) Number
- K173909 FDA UDI
- FDA Product Code
- PDJ FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1373 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
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
Category: Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Dimension Clinical Chemistry System A1C Kit by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry.
- Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application — Roche Diagnostics Corp. · Class II
- Tinaquant Hemoglobin A1c III — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Tina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics Corp. · Class II
- Tinaquant Hemoglobin A1c Gen2 Whole blood and Hemolysate Application — Roche Diagnostics Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Tinaquant Hemoglobin A1c Gen2 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K173909 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 110a0dd9-f385-4995-9513-bfa508b1b3a7 37 fields · synced May 30, 2026