Antiserum, Positive And Negative Febrile Antigen Control Serum
The Antiserum, Positive and Negative Febrile Antigen Control Serum is a reference control serum used in febrile antigen agglutination tests, providing both positive and negative controls to validate assay performance for the detection of bacterial infections including Brucella. It is an FDA Class 2 device, meaning it presents moderate risk and requires 510(k) premarket notification. Regulated under 21 CFR 866.3085 with product code GSN in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSN
- Device Class
- FDA class 2
- Regulation Number
- 866.3085
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952145 | SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM | Jul 18, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K885113 | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL | Aug 15, 1989 | Substantially Equivalent | Investigacion Farmaceutica S.A. DE C.V. |
| K791385 | NEGATIVE CONTROL SERUM FOR CF RO ID | Aug 16, 1979 | Substantially Equivalent | Immuno-Mycologics, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.