21 CFR 862.1160 — Titrimetric Phenol Red, Carbon-Dioxide

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1160

Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CHRTitrimetric Phenol Red, Carbon-Dioxide203rd Party
CHSCoulometric Method, Carbon-Dioxide263rd Party
CIEVolumetric/Manometric, Carbon-Dioxide273rd Party
CILCresol Red Colorimetry, Carbon-Dioxide243rd Party
JFLPh Rate Measurement, Carbon-Dioxide2283rd Party
KHSEnzymatic, Carbon-Dioxide2863rd Party
KMSPhenolphthalein Colorimetry, Carbon-Dioxide253rd Party
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...