Identity
- Trade Name
- ADVIA 120/2120/2120i® AUTOretic FDA UDI
- Generic Name
- Reticulocyte count IVD, kit, cell count FDA UDI
- Device Name
- ADVIA®120/2120/2120i autoRETIC FDA UDI
- Model / Reference
- 10312271 FDA UDI
- Description
- ADVIA®120/2120/2120i autoRETIC FDA UDI
Identifiers
- Catalog Number
- T01-3622-54 FDA UDI
- Primary DI / UDI-DI
- 00630414222912 FDA UDI
- 510(k) Number
- K971998 FDA UDI
- FDA Product Code
- GKL FDA UDI
- GMDN Term
- Reticulocyte count IVD, kit, cell count 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: Reticulocyte count IVD, kit, cell count
ADVIA 120/2120/2120i® AUTOretic by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Reticulocyte count IVD, kit, cell count.
- Alinity — Abbott Ireland Diagnostics · Class I
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- RET-SEARCH II — Sysmex Corp. · Class I
- ADVIA 120/2120/2120i® autoRETIC — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K971998 also covers:
- 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® 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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI d9286257-0c96-47e2-abfa-8152d1a5b8f2 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 18, 2026