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RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, calibrator FDA UDI
- Device Name
- RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution FDA UDI
- Model / Reference
- 10318630 FDA UDI
- Description
- RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution FDA UDI
Identifiers
- Catalog Number
- 3279837 FDA UDI
- Primary DI / UDI-DI
- 00630414452319 FDA UDI
- 510(k) Number
- K974526 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, calibrator 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas analyte IVD, calibrator
RAPIDChem® 700 RAPIDPoint® 340/350 Red Test Dye Solution by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Multiple blood gas analyte IVD, calibrator.
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Cleared under the same submission
K974526 also covers:
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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2c3d6f23-d25d-411b-ba80-187aa4456eca 37 fields · synced May 30, 2026