Plates And Equipment, Radial Immunodiffusion

Device Code: 3016

Product Code(s): JZQ

Device Classification Information

Device Type ID3016
Device NamePlates And Equipment, Radial Immunodiffusion
Regulation DescriptionRadial Immunodiffusion Plate.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJZQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3016
DevicePlates And Equipment, Radial Immunodiffusion
Product CodeJZQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadial Immunodiffusion Plate.
CFR Regulation Number866.4800 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
The Binding Site Group, Ltd.
II Jan-19-2017
TPLC Last Update: 2019-04-02 20:22:39

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