Reagents, Specific, Analyte
Specific Analyte Reagents are laboratory reagents used in immunohistochemical, immunofluorescent, or enzyme-linked staining techniques to identify and localize specific antigens or analytes in tissue sections or cell preparations for pathological diagnosis. They are classified as FDA Class 1, subject to general controls, with product code MVU under 21 CFR 864.4020 in the Pathology specialty. No premarket submission is required. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MVU
- Device Class
- FDA class 1
- Regulation Number
- 864.4020
- Medical Specialty
- Pathology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 117 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 117 registration numbers. Click on an entry to view related FDA registrations.