Antiserum, Vibrio Cholerae, All Varieties
The Antiserum, Vibrio Cholerae, All Varieties is a laboratory antiserum covering all serological varieties of Vibrio cholerae, used in agglutination tests to identify cholera-causing bacteria in clinical specimens. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is GSQ, regulated under 21 CFR 866.3930 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSQ
- Device Class
- FDA class 2
- Regulation Number
- 866.3930
- 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 |
|---|---|---|---|---|
| K954995 | QUIX RAPID CHOLERA STRIP TEST | Aug 15, 1996 | Substantially Equivalent | Guardian Scientific, Corp. |
| K932622 | CHOLERA SMART(TM) | Jun 27, 1995 | Substantially Equivalent | New Horizons Diagnostics Co. |
| K922432 | CHOLERASCREEN | Dec 07, 1992 | Substantially Equivalent | New Horizons Diagnostics Co. |
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.