Identity
- Trade Name
- Sirrus® Bicarbonate (CO2) LiquiColor® FDA UDI
- Generic Name
- Carbon dioxide (CO2) IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. FDA UDI
- Model / Reference
- S0190-750 FDA UDI
- Description
- For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. FDA UDI
Identifiers
- Catalog Number
- S0190-750 FDA UDI
- Primary DI / UDI-DI
- 00657498001479 FDA UDI
- FDA Product Code
- KHS FDA UDI
- GMDN Term
- Carbon dioxide (CO2) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1160 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
Yes
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: Carbon dioxide (CO2) IVD, kit, spectrophotometry
Sirrus® Bicarbonate (CO2) LiquiColor® by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Carbon dioxide (CO2) IVD, kit, spectrophotometry.
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- Yumizen C1200 CO2 — Horiba Abx · Class II
- Bicarbonate Liquid — Roche Diagnostics Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- ARCHITECT — Abbott · Class II
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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI d4d91a81-0f17-43c3-84c3-8518e8f4b5a2 36 fields · synced May 31, 2026