Identity
- Trade Name
- RAPIDChem® 700 Chloride Sensor FDA UDI
- Generic Name
- Chloride (Cl-) electrode IVD FDA UDI
- Device Name
- RAPIDChem® 700 Chloride Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems FDA UDI
- Model / Reference
- 10308989 FDA UDI
- Description
- RAPIDChem® 700 Chloride Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems FDA UDI
Identifiers
- Catalog Number
- 661439 FDA UDI
- Primary DI / UDI-DI
- 00630414451855 FDA UDI
- 510(k) Number
- K000926 FDA UDI
- FDA Product Code
- CEM FDA UDIJGS FDA UDICGZ FDA UDI
- GMDN Term
- Chloride (Cl-) electrode IVD 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chloride (Cl-) electrode IVD
RAPIDChem® 700 Chloride Sensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chloride (Cl-) electrode IVD.
- ABX PENTRA CHLORIDE-E — Horiba Abx · Class II
- Chloride Electrode — Medica Corp. · Class II
- CL ELECTRODE, ISE MODULE — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- I.S.E. CL — Randox Laboratories, Ltd. · Class II
- ISE Chloride Electrode — Medica Corp. · Class II
- Chloride Electrode — Medica Corp. · Class II
- Chloride Electrode — DIAMOND DIAGNOSTICS Inc
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 RAPIDPoint® 340/350 Reference 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2ae57f09-86a0-45df-8169-6251123ea7e4 37 fields · synced May 30, 2026