Identity
- Trade Name
- RAPIDChem® 754 Na+K+Li+ Reagent Module FDA UDI
- Generic Name
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- RAPIDChem® 754 Na+ K+ Li+ Reagent Module, for in vitro diagnostics use with the Rapidchem® 754 systems. FDA UDI
- Model / Reference
- 10309093 FDA UDI
- Description
- RAPIDChem® 754 Na+ K+ Li+ Reagent Module, for in vitro diagnostics use with the Rapidchem® 754 systems. FDA UDI
Identifiers
- Catalog Number
- 5840552 FDA UDI
- Primary DI / UDI-DI
- 00630414451824 FDA UDI
- 510(k) Number
- K002407 FDA UDI
- FDA Product Code
- JGS FDA UDICEM FDA UDIJIH FDA UDI
- GMDN Term
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1600 FDA UDI862.3560 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: Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
RAPIDChem® 754 Na+K+Li+ Reagent Module 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 4d5fc401-7ea9-4e11-bd6c-bd6e7ba1599e 37 fields · synced May 30, 2026