Media, Culture, Amino Acid Assay

Device Code: 3332

Product Code(s): JRZ

Device Classification Information

Device Type ID3332
Device NameMedia, Culture, Amino Acid Assay
Regulation DescriptionMicrobiological Assay Culture Medium.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.2350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJRZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3332
DeviceMedia, Culture, Amino Acid Assay
Product CodeJRZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicrobiological Assay Culture Medium.
CFR Regulation Number866.2350 [🔎]
TPLC Last Update: 2019-04-02 20:27:46

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