Identity
- Trade Name
- ADVIA 120/2120/2120i® OPTIpoint FDA UDI
- Generic Name
- Full blood count IVD, calibrator FDA UDI
- Device Name
- ADVIA®120/2120/2120i OPTIpoint™ FDA UDI
- Model / Reference
- 10319591 FDA UDI
- Description
- ADVIA®120/2120/2120i OPTIpoint™ FDA UDI
Identifiers
- Catalog Number
- T03-3682-01 FDA UDI
- Primary DI / UDI-DI
- 00630414224305 FDA UDI
- 510(k) Number
- K971998 FDA UDI
- FDA Product Code
- GKL FDA UDI
- GMDN Term
- Full blood count IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5200 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
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
Category: Full blood count IVD, calibrator
ADVIA 120/2120/2120i® OPTIpoint by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K971998 also covers:
- ADVIA 120/2120/2120i® AUTOretic — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® DIFF TIMEpac — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® Defoamer — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® OPTIpoint — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® Perox Sheath — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® Sheath/Rinse — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® Sheath/Rinse — Siemens Healthcare Diagnostics
- ADVIA 120/2120/2120i® autoRETIC — Siemens Healthcare Diagnostics
- ADVIA® 120 Hematology System — Siemens Healthcare Diagnostics
- ADVIA® 120 Hematology System — Siemens Healthcare Diagnostics
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 594ca482-9970-4e42-9341-12da387f576f 37 fields · synced May 29, 2026