Dna-reagents, Chlamydia

Device Code: 3454

Product Code(s): LSK

Device Classification Information

Device Type ID3454
Device NameDna-reagents, Chlamydia
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 CodeLSK
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 ID3454
DeviceDna-reagents, Chlamydia
Product CodeLSK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionChlamydia Serological Reagents.
CFR Regulation Number866.3120 [🔎]
TPLC Last Update: 2019-04-02 20:30:25

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