Atellica CH Lithium_2 (LITH_2)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Atellica CH Lithium_2 (LITH_2) EUDAMEDFDA UDI
- Generic Name
- Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_REAG_LITH EUDAMEDLithium_2 (LITH_2) Atellica CH - RGT 400T FDA UDI
- Model / Reference
- 11532401 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_REAG_LITH EUDAMED
- Description
- Lithium_2 (LITH_2) Atellica CH - RGT 400T FDA UDI
Identifiers
- Catalog Number
- 11532401 FDA UDI
- Primary DI / UDI-DI
- 00630414287935 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901740VR EUDAMED
- 510(k) Number
- K050374 FDA UDI
- FDA Product Code
- NDW FDA UDI
- EMDN Code
- W01010305 LITHIUM EUDAMED
- GMDN Term
- Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3560 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: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Atellica CH Lithium_2 (LITH_2) by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy.
Cleared under the same submission
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 950604ad-3ba5-47df-a473-f69602583c85 37 fields · synced Jul 14, 2026
- EUDAMED 1222ee93-0c55-4186-bdab-f12d62780cdd 61 fields · synced Jul 14, 2026