Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
This is an immunological reagent kit for detecting antismooth muscle antibodies (ASMA) using an indirect immunofluorescence technique, providing antigen substrate and control components for identifying autoantibodies associated with autoimmune hepatitis, primary biliary cirrhosis, and other autoimmune conditions. 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 DBE, regulated under 21 CFR 866.5120, within the Immunology specialty.
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Basic Information
- Product Code
- DBE
- Device Class
- FDA class 2
- Regulation Number
- 866.5120
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | May 01, 1981 | Substantially Equivalent | Immuno-Products Industries |
| K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | Apr 24, 1980 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | Feb 21, 1980 | Substantially Equivalent | Clinical Sciences, Inc. |
| K790430 | MEDICA II-F-ASMA TEST KIT | Apr 23, 1979 | Substantially Equivalent | Medica Corp. |
| K771155 | ANTI-MITOCHONDRIAL | Aug 04, 1977 | Substantially Equivalent | Meloy Laboratories, Inc. |
| K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Jul 20, 1976 | Substantially Equivalent | Zeus Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.