Identity
- Trade Name
- ADVIA Chemistry Lithium_2 (LITH_2) reagents FDA UDI
- Generic Name
- Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy FDA UDI
- Device Name
- Lithium_2 (LITH_2) ADVIA Chemistry - RGT 200T FDA UDI
- Model / Reference
- 11532400 FDA UDI
- Description
- Lithium_2 (LITH_2) ADVIA Chemistry - RGT 200T FDA UDI
Identifiers
- Catalog Number
- 11532400 FDA UDI
- Primary DI / UDI-DI
- 00630414288178 FDA UDI
- 510(k) Number
- K050374 FDA UDI
- FDA Product Code
- NDW FDA UDI
- GMDN Term
- Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3560 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: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
ADVIA Chemistry Lithium_2 (LITH_2) reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy.
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 b75a6575-dc86-4e1b-b2f9-5bd54d900a61 37 fields · synced Jun 6, 2026