Antisera, All Types, Shigella Spp.

Device Code: 3177

Product Code(s): GNB

Device Classification Information

Device Type ID3177
Device NameAntisera, All Types, Shigella Spp.
Regulation DescriptionShigella Spp. Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGNB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3177
DeviceAntisera, All Types, Shigella Spp.
Product CodeGNB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionShigella Spp. Serological Reagents.
CFR Regulation Number866.3660 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Remel Inc
II Dec-26-2017
TPLC Last Update: 2019-04-02 20:25:05

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