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
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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
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Summary Malfunction Reporting