ADVIA 120/2120/2120i® DIFF TIMEpac
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA 120/2120/2120i® DIFF TIMEpac EUDAMEDFDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_A_REAG_DIFF TIMEPAC EUDAMEDADVIA®120/2120/2120i DIFF TIMEPAC® FDA UDI
- Model / Reference
- 10312270 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_A_REAG_DIFF TIMEPAC EUDAMED
- Description
- ADVIA®120/2120/2120i DIFF TIMEPAC® FDA UDI
Identifiers
- Catalog Number
- T01-3621-52 FDA UDI
- Primary DI / UDI-DI
- 00630414222899 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900786WA EUDAMED
- 510(k) Number
- K971998 FDA UDI
- FDA Product Code
- GKL FDA UDI
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
- GMDN Term
- White blood cell count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: White blood cell count IVD, kit, cell count
ADVIA 120/2120/2120i® DIFF TIMEpac by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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® 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
IVDR
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI cbf00fa4-f5d5-43c4-bd65-3c3d5c6a66f9 37 fields · synced Jul 10, 2026
- EUDAMED 20a03296-a34b-4c4c-aac2-3620863adfd3 61 fields · synced Jul 10, 2026