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K Number
K961538
Device Name
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
1996-05-20

(28 days)

Product Code
GNB
Regulation Number
866.3660
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 866.3660

Shigella spp. serological reagents.(a)
Identification. Shigella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identifyShigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genusShigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.(b)
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.