Carbon Dioxide Reagent

FDA UDI

Class II (US FDA UDI)

by Clinical Diagnostic Solutions, Inc.

Identity

Trade Name: Carbon Dioxide Reagent FDA UDI
Generic Name: Carbon dioxide (CO2) IVD, reagent FDA UDI
Device Name: For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. FDA UDI
Model / Reference: 120mL FDA UDI
Description: For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only. FDA UDI

Identifiers

Catalog Number: 501-407 FDA UDI
Primary DI / UDI-DI: 00812137011947 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Carbon dioxide (CO2) IVD, reagent

Carbon Dioxide Reagent by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbon dioxide (CO2) IVD, reagent.

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Teco Diagnostics Carbon Dioxide (CO2) Reagent Set — TECO DIAGNOSTICS · 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

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: Clinical Diagnostic Solutions, Inc.

Sources (1)

FDA UDI c44f711c-8180-4280-b685-7c3f0caae19c 36 fields · synced May 30, 2026