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
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FEI Numbers
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Registration Numbers
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Unique Applicants
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Years Active
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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
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Summary Malfunction Reporting