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ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10341169Model IVDR_67_TTN_DUB-C_A_INST_CN-Free CBC TIMEPACRef 10312269Model IVDR_67_TTN_DUB-C_A_REAG_CBC TIMEPAC
Identity
- Trade Name
- ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC EUDAMEDFDA UDIADVIA® 120/2120/2120i CBC TIMEpac EUDAMEDFDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_A_INST_CN-Free CBC TIMEPAC EUDAMEDIVDR_67_TTN_DUB-C_A_REAG_CBC TIMEPAC EUDAMEDIVD Complete Blood Count Kit CN-FREE FDA UDIADVIA®120/2120/2120i CBCTIMEPAC® FDA UDI
- Model / Reference
- 10341169 EUDAMEDFDA UDI10312269 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_A_INST_CN-Free CBC TIMEPAC EUDAMEDIVDR_67_TTN_DUB-C_A_REAG_CBC TIMEPAC EUDAMED
- Description
- IVD Complete Blood Count Kit CN-FREE FDA UDIADVIA®120/2120/2120i CBCTIMEPAC® FDA UDI
Identifiers
- Catalog Number
- T01-3626-52 FDA UDIT01-3620-52 FDA UDI
- Primary DI / UDI-DI
- 00630414222950 EUDAMEDFDA UDI00630414222882 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900840VP EUDAMED0405686900776W7 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
- Full blood 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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, kit, cell count
ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K971998 also covers:
- ADVIA 120/2120/2120i® AUTOretic — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (4)
- FDA UDI 15c4f866-161b-4511-914c-465532fbb9bc 37 fields · synced Oct 6, 2026
- FDA UDI 0c53c738-a093-4ce3-bce7-42d49c342f69 37 fields · synced May 30, 2026
- EUDAMED bf3c77f6-98f2-451c-91ae-bae0897fc824 61 fields · synced Jul 15, 2026
- EUDAMED 7f624605-8a9a-4356-8a55-c537d770132f 61 fields · synced Jul 15, 2026