Identity
- Trade Name
- RAPIDLab® Reference Electrode Fill FDA UDI
- Generic Name
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
- Device Name
- RAPIDLab® series Reference Electrode Fill Solution. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers. FDA UDI
- Model / Reference
- 10311081 FDA UDI
- Description
- RAPIDLab® series Reference Electrode Fill Solution. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers. FDA UDI
Identifiers
- Catalog Number
- 478822 FDA UDI
- Primary DI / UDI-DI
- 00630414117539 FDA UDI
- 510(k) Number
- K935830 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 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: Ion selective electrode (ISE) reference solution IVD, reagent
RAPIDLab® Reference Electrode Fill by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ion selective electrode (ISE) reference solution IVD, reagent.
- Alfa Wassermann — Alfa Wassermann, Inc.
- Carolina Liquid Chemistries Corp. ISE Diluent DT88810 — Carolina Liquid Chemistries Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Internal Filling Solution — Medica Corp. · Class II
- ENVOY 500 ISE REFERENCE SOLUTION KIT — VITALSCIENTIFIC
- ENVOY 500 ISE REFERENCE SOLUTION KIT — VITALSCIENTIFIC
- ISE Reference Reagent — DIAMOND DIAGNOSTICS Inc
- ISE Reference Reagent — DIAMOND DIAGNOSTICS Inc
Cleared under the same submission
K935830 also covers:
- RAPIDLab® 248 6.8/7.3 Buffer — Siemens Healthcare Diagnostics
- RAPIDLab® 248 Wash — Siemens Healthcare Diagnostics
- RAPIDLab® Na+/K+/Ca++/Cl- Electrode Fill — Siemens Healthcare Diagnostics
- RAPIDLab® pH Electrode Fill — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Potassium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Reference Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Reference Sensor Refill — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Sodium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD pO2 Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Gold pCO2 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 2eb69b80-7538-4db8-b3e6-e3451a16bb6b 37 fields · synced May 30, 2026