Identity
- Trade Name
- RAPIDSystems™ AutomaticQC Cartridge FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only. FDA UDI
- Model / Reference
- 11046781 FDA UDI
- Description
- for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only. FDA UDI
Identifiers
- Catalog Number
- 11046781 FDA UDI
- Primary DI / UDI-DI
- 00630414016627 FDA UDI
- 510(k) Number
- K002738 FDA UDI
- FDA Product Code
- CEM FDA UDICGA FDA UDIJGS FDA UDICGZ FDA UDICHL FDA UDIGKF FDA UDIJFP FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1345 FDA UDI862.1665 FDA UDI862.1170 FDA UDI862.1120 FDA UDI864.5600 FDA UDI862.1145 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
RAPIDSystems™ AutomaticQC Cartridge by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, control.
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- i-STAT — Abbott Point of Care Inc. · Class I
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Cleared under the same submission
K002738 also covers:
- RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics
- RAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics
- TB1 pO2/pCO2 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 0d36ac11-aad4-49db-bbd2-5d793ae05be5 37 fields · synced Jun 8, 2026