Identity
- Trade Name
- Teco Diagnostics Carbon Dioxide (CO2) Reagent Set FDA UDI
- Generic Name
- Carbon dioxide (CO2) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Carbon Dioxide (CO2) Reagent Set is used for manual or automated quantitative determination of carbon dioxide content in human plasma or serum at 340 nm. FDA UDI
- Model / Reference
- C525-60 FDA UDI
- Description
- Teco Diagnostics Carbon Dioxide (CO2) Reagent Set is used for manual or automated quantitative determination of carbon dioxide content in human plasma or serum at 340 nm. FDA UDI
Identifiers
- Catalog Number
- C525-60 FDA UDI
- Primary DI / UDI-DI
- 10673486001624 FDA UDI
- 510(k) Number
- K942735 FDA UDI
- FDA Product Code
- KHS FDA UDI
- GMDN Term
- Carbon dioxide (CO2) IVD, reagent 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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, reagent
Teco Diagnostics Carbon Dioxide (CO2) Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide (CO2) IVD, reagent.
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- ClearChem Diagnostics Inc. Carbon Dioxide (CO2) — CLEARCHEM DIAGNOSTICS INC. · Class II
- ACE — Alfa Wassermann, Inc. · Class II
- CO2 Reagent — DIAMOND DIAGNOSTICS Inc
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Carbon Dioxide Reagent — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · 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
- Teco Diagnostics
Sources (1)
- FDA UDI 63a9aa01-2fc4-4271-8657-4eb4bfe1dd11 37 fields · synced May 30, 2026