21 CFR 866.5430 — Beta-2-Glycoprotein I, Antigen, Antiserum, Control

Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5430

Identification

A beta-2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2-glycoprotein I aids in the diagnosis of an inherited deficiency of this serum protein.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control10
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...