21 CFR 862.1145 — Titrimetric Permanganate And Bromophenol Blue, Calcium

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1145

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CHCTitrimetric Permanganate And Bromophenol Blue, Calcium203rd Party
CHWTitrimetric With Edta And Indicator, Calcium233rd Party
CHZDi (O-Hydroxyphenylimine) Ethane, Calcium213rd Party
CIAMethylthymol Blue, Calcium253rd Party
CICCresolphthalein Complexone, Calcium2993rd Party
CIDAlizarin Sulfonate, Calcium223rd Party
CJYAzo Dye, Calcium2473rd Party
JFNAtomic Absorption, Calcium233rd Party
JFOFluorometric, Calcium213rd Party
JFPElectrode, Ion Specific, Calcium2293rd Party
Innolitics

Panel 1

/
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...