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ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Device Name
- HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests) FDA UDI
- Model / Reference
- 10286032 FDA UDI
- Description
- HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests) FDA UDI
Identifiers
- Catalog Number
- 4795367 FDA UDI
- Primary DI / UDI-DI
- 00630414555140 FDA UDI
- 510(k) Number
- K081895 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
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 08a43590-95cf-413f-bb38-7a1b1bb2f15b 38 fields · synced Jun 8, 2026