Identity
- Trade Name
- RAPIDQC® Complete Level 3 FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. FDA UDI
- Model / Reference
- 10309927 FDA UDI
- Description
- For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. FDA UDI
Identifiers
- Catalog Number
- 108869 FDA UDI
- Primary DI / UDI-DI
- 00630414202167 FDA UDI
- 510(k) Number
- K970956 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
RAPIDQC® Complete Level 3 by Siemens Healthcare Diagnostics — Class I — 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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Cleared under the same submission
K970956 also covers:
- CVM® Calibration Verification Material — Siemens Healthcare Diagnostics
- CVM® Hct Calibration Verification Material for Hematocrit Systems — Siemens Healthcare Diagnostics
- Proficiency Pre-Test — Siemens Healthcare Diagnostics
- RAPIDLab® High G/L — Siemens Healthcare Diagnostics
- RAPIDQC® Complete Level 1 — Siemens Healthcare Diagnostics
- RAPIDQC® Complete Level 2 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2a769908-194f-4717-95d9-c9673d219ef0 37 fields · synced May 30, 2026