GSQ · Antiserum, Vibrio Cholerae, All Varieties
Microbiology · 21 CFR 866.3930 · Class 2
Overview
| Product Code | GSQ |
|---|---|
| Device Name | Antiserum, Vibrio Cholerae, All Varieties |
| Regulation | 21 CFR 866.3930 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Vibrio cholerae serological reagents are devices that are used in the agglutination (an antigen-antibody clumping reaction) test to identify Vibrio cholerae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cholera caused by the bacterium Vibrio cholerae and provides epidemiological information on cholera. Cholera is an acute infectious disease characterized by severe diarrhea with extreme fluid and electrolyte (salts) depletion, and by vomiting, muscle cramps, and prostration. If untreated, the severe dehydration may lead to shock, renal failure, cardiovascular collapse, and death.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954995 | QUIX RAPID CHOLERA STRIP TEST | Guardian Scientific, Corp. | Aug 15, 1996 | SESE |
| K932622 | CHOLERA SMART(TM) | New Horizons Diagnostics Co. | Jun 27, 1995 | SESE |
| K922432 | CHOLERASCREEN | New Horizons Diagnostics Co. | Dec 7, 1992 | SESE |
Top Applicants
- New Horizons Diagnostics Co. — 2 clearances
- Guardian Scientific, Corp. — 1 clearance
