Identity
- Trade Name
- TB4 Glu/Lac Test/Blank Sensor FDA UDI
- Generic Name
- Lactate electrode IVD FDA UDI
- Device Name
- Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems. FDA UDI
- Model / Reference
- 10326708 FDA UDI
- Description
- Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems. FDA UDI
Identifiers
- Catalog Number
- 673701000 FDA UDI
- Primary DI / UDI-DI
- 00630414132051 FDA UDI
- 510(k) Number
- K031560 FDA UDI
- FDA Product Code
- KHP FDA UDICGZ FDA UDIGKR FDA UDICEM FDA UDIJFP FDA UDICHL FDA UDIJGS FDA UDICGA FDA UDI
- GMDN Term
- Lactate electrode IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1450 FDA UDI862.1170 FDA UDI864.5620 FDA UDI862.1600 FDA UDI862.1145 FDA UDI862.1120 FDA UDI862.1665 FDA UDI862.1345 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
TB4 Glu/Lac Test/Blank Sensor by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactate electrode IVD.
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- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K031560 also covers:
- RAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1240 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1245 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1260 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1265 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series CO-ox Sample Chamber — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Systems Reagent Cartridge — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Systems Wash Cartridge — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 pH Electrode Fill — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Calcium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Chloride Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Electrode pCO2 — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 8a7251e1-1450-4e55-a8e6-e7f70a4080ea 36 fields · synced Jun 8, 2026