Identity
- Trade Name
- Ready Sensor™ GOLD Reference Sensor FDA UDI
- Generic Name
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
- Device Name
- Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 248/348/348ex instruments FDA UDI
- Model / Reference
- 10323084 FDA UDI
- Description
- Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 248/348/348ex instruments FDA UDI
Identifiers
- Catalog Number
- 476273 FDA UDI
- Primary DI / UDI-DI
- 00630414112206 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
Ready Sensor™ GOLD Reference Sensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ion selective electrode (ISE) reference solution IVD, reagent.
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- 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® Reference 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 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 6928c050-0e32-4287-8560-23f5334b67bf 37 fields · synced May 30, 2026