Identity
- Trade Name
- Ready Sensor™ Lactate Biosensor FDA UDI
- Generic Name
- Lactate electrode IVD FDA UDI
- Device Name
- Ready Sensor™ Lactate Biosensor is an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems. FDA UDI
- Model / Reference
- 10316526 FDA UDI
- Description
- Ready Sensor™ Lactate Biosensor is an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems. FDA UDI
Identifiers
- Catalog Number
- 2144067 FDA UDI
- Primary DI / UDI-DI
- 00630414468143 FDA UDI
- 510(k) Number
- K934907 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Lactate electrode IVD 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lactate electrode IVD
Ready Sensor™ Lactate Biosensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactate electrode IVD.
- Membrane for E7077 electrode — Radiometer Medical ApS · Class I
- Electrode for ABL analyzers — Radiometer Medical ApS · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
- TB4 Glu/Lac Test/Blank Sensor — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K934907 also covers:
- RL 1200 Waste Bottle Kit — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Calcium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Glucose Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Glucose Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- TB1 pO2/pCO2 Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB2 pH/Na+ Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB3 K+/Ca++/Cl- Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB5 Ref Test/Blank 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 4adf0ea6-4ebe-4699-8981-ffc76b229d4d 37 fields · synced May 30, 2026