Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
This is an immunological reagent kit for detecting antiparietal cell antibodies using indirect immunofluorescence, providing antigen substrate and control components for diagnosing autoimmune conditions affecting the stomach, including autoimmune gastritis and pernicious anemia. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DBJ, regulated under 21 CFR 866.5110, within the Immunology specialty.
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Basic Information
- Product Code
- DBJ
- Device Class
- FDA class 2
- Regulation Number
- 866.5110
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.