Antisera, Fluorescent, Chlamydia Spp.

Device Code: 3424

Product Code(s): LKI

Device Classification Information

Device Type ID3424
Device NameAntisera, Fluorescent, Chlamydia Spp.
Regulation DescriptionChlamydia Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3120 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLKI
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 ID3424
DeviceAntisera, Fluorescent, Chlamydia Spp.
Product CodeLKI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionChlamydia Serological Reagents.
CFR Regulation Number866.3120 [🔎]
TPLC Last Update: 2019-04-02 20:29:28

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