Transport Systems, Anaerobic

Device Code: 3367

Product Code(s): JTX

Device Classification Information

Device Type ID3367
Device NameTransport Systems, Anaerobic
Regulation DescriptionMicrobiological Specimen Collection And Transport Device.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.2900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJTX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID3367
DeviceTransport Systems, Anaerobic
Product CodeJTX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicrobiological Specimen Collection And Transport Device.
CFR Regulation Number866.2900 [🔎]
TPLC Last Update: 2019-04-02 20:28:18

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