SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM

• K Number: K961549
• Device Name: SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
• Manufacturer: SA SCIENTIFIC, INC.
• Date Cleared: 1996-05-20 ( 28 days)
• Product Code: GNB
• Regulation Number: 866.3660

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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