Antiserum, Rocky Mountain Spotted Fever

Device Code: 3233

Product Code(s): GPP

Device Classification Information

Device Type ID3233
Device NameAntiserum, Rocky Mountain Spotted Fever
Regulation DescriptionRickettsia Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGPP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3233
DeviceAntiserum, Rocky Mountain Spotted Fever
Product CodeGPP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRickettsia Serological Reagents.
CFR Regulation Number866.3500 [🔎]
TPLC Last Update: 2019-04-02 20:26:07

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