Product Code: CZR FDA class 2 21 CFR 866.5490

Hemopexin, Rhodamine, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and quantifying hemopexin, a plasma glycoprotein involved in heme transport and protection against oxidative stress. The kit uses rhodamine as a fluorescent label and includes antigen, antiserum, and control components for immunoassay procedures performed in clinical laboratories. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is CZR, regulated under 21 CFR 866.5490, and falls within the Immunology medical specialty.

510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active

Basic Information

Product Code
CZR
Device Class
FDA class 2
Regulation Number
866.5490
Medical Specialty
Immunology
Review Panel
IM
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting