Whole Blood Plasma, Antigen, Antiserum, Control
The Whole Blood Plasma Antigen, Antiserum, and Control is an immunological reagent used to detect and characterize proteins and other analytes in whole blood or plasma specimens, serving as a reference material in clinical immunological testing. It is classified as FDA Class 1, indicating low risk and requiring only general controls without premarket notification. The device is regulated under 21 CFR 866.5700 within the Immunology specialty.
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Basic Information
- Product Code
- DGQ
- Device Class
- FDA class 1
- Regulation Number
- 866.5700
- Medical Specialty
- Immunology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K791282 | ANTI-HUMAN SERUM | Oct 17, 1979 | Substantially Equivalent | Diagnostica, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.