Product Code: DEC FDA class 1 21 CFR 866.5890

Inter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting inter-alpha trypsin inhibitor (ITI), a plasma serine protease inhibitor involved in extracellular matrix stabilization and inflammation regulation, using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence analysis. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DEC, regulated under 21 CFR 866.5890, within the Immunology specialty.

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

Basic Information

Product Code
DEC
Device Class
FDA class 1
Regulation Number
866.5890
Medical Specialty
Immunology
Review Panel
IM
Submission Type
4

Device Characteristics

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