Cryptosporidium Spp.

Device Code: 3485

Product Code(s): MHJ

Device Classification Information

Device Type ID3485
Device NameCryptosporidium Spp.
Regulation DescriptionEntamoeba Histolytica Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3220 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMHJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3485
DeviceCryptosporidium Spp.
Product CodeMHJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEntamoeba Histolytica Serological Reagents.
CFR Regulation Number866.3220 [🔎]
Premarket Reviews
ManufacturerDecision
TECHLAB, INC.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:30:58

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