Staphylococcus Aureus Protein A Insoluble

Device Code: 3397

Product Code(s): LHJ

Device Classification Information

Device Type ID3397
Device NameStaphylococcus Aureus Protein A Insoluble
Regulation DescriptionStaphylococcus Aureus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3700 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLHJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3397
DeviceStaphylococcus Aureus Protein A Insoluble
Product CodeLHJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionStaphylococcus Aureus Serological Reagents.
CFR Regulation Number866.3700 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Integrated Science Systems Inc
II Jun-03-2016
TPLC Last Update: 2019-04-02 20:28:55

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