Antiserum, Pseudomonas Pseudomallei

Device Code: 3304

Product Code(s): GST

Device Classification Information

Device Type ID3304
Device NameAntiserum, Pseudomonas Pseudomallei
Regulation DescriptionPseudomonas 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 Number866.3415 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGST
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3304
DeviceAntiserum, Pseudomonas Pseudomallei
Product CodeGST
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPseudomonas Spp. Serological Reagents.
CFR Regulation Number866.3415 [🔎]
TPLC Last Update: 2019-04-02 20:27:20

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