Identity
- Trade Name
- Sensor Module, Li+ FDA UDI
- Generic Name
- Ion-selective analyser IVD, semi-automated FDA UDI
- Device Name
- Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer FDA UDI
- Model / Reference
- 10318482 FDA UDI
- Description
- Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer FDA UDI
Identifiers
- Catalog Number
- 3191840 FDA UDI
- Primary DI / UDI-DI
- 00630414484563 FDA UDI
- 510(k) Number
- K000926 FDA UDI
- FDA Product Code
- CEM FDA UDIJGS FDA UDICGZ FDA UDI
- GMDN Term
- Ion-selective analyser IVD, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1665 FDA UDI862.1170 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ion-selective analyser IVD, semi-automated
Sensor Module, Li+ by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ion-selective analyser IVD, semi-automated.
- SelectaLyte — AWARENESS TECHNOLOGY, INCORPORATED · Class I
- RAPIDChem® 744 — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K000926 also covers:
- Chloride Electrode — Medica Corp.
- EasyElectrolyte Reagent Module, Na/K/Cl Analyzers — Medica Corp.
- ISE Chloride Electrode — Medica Corp.
- ISE Cleaning Solution Kit — Medica Corp.
- ISE Disposable Reference Electrode — Medica Corp.
- ISE Potassium Electrode — Medica Corp.
- ISE Reagent Module — Medica Corp.
- ISE Reagent Pack — Medica Corp.
- ISE Sodium electrode — Medica Corp.
- ISE eChloride Electrode — Medica Corp.
- Na/K/Cl Analyzer — Medica Corp.
- RAPIDChem® 700 Chloride Sensor — Siemens Healthcare Diagnostics
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 ff54d7b5-4e2c-4e31-bb32-09a44057ab5a 36 fields · synced May 30, 2026