Identity
- Trade Name
- ADVIA® 120/2120/2120i TESTpoint Normal Control FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- ADVIA®120/2120/2120i Testpoint™ Norm Control FDA UDI
- Model / Reference
- 10312289 FDA UDI
- Description
- ADVIA®120/2120/2120i Testpoint™ Norm Control FDA UDI
Identifiers
- Catalog Number
- T03-3687-54 FDA UDI
- Primary DI / UDI-DI
- 00630414224381 FDA UDI
- 510(k) Number
- K896154 FDA UDI
- FDA Product Code
- JCN FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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, control
ADVIA® 120/2120/2120i TESTpoint Normal Control 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
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 4ff811b6-8db1-4b9f-9946-68217b2d3144 37 fields · synced Jun 7, 2026