Alpha-1 Microglobulin, Antigen, Antiserum, Control
The alpha-1 microglobulin antigen, antiserum, and control reagents are immunology in vitro diagnostic devices used to detect and quantify alpha-1 microglobulin in patient specimens, supporting assessment of renal tubular function and protein metabolism disorders. They are classified as FDA Class I under 21 CFR 866.5400 within the Immunology specialty, subject only to general controls. The product code is MGA and the devices are not GMP-exempt. They are not implanted and do not sustain life.
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Basic Information
- Product Code
- MGA
- Device Class
- FDA class 1
- Regulation Number
- 866.5400
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K965033 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT | Apr 21, 1997 | Substantially Equivalent | Beckman Instruments, Inc. |
| K933078 | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT | Jan 11, 1994 | Substantially Equivalent | Beckman Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.