Anti-rnp Antibody, Antigen And Control

Device Code: 3033

Product Code(s): LKO

Device Classification Information

Device Type ID3033
Device NameAnti-rnp Antibody, Antigen And Control
Regulation DescriptionAntinuclear Antibody Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLKO
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 ID3033
DeviceAnti-rnp Antibody, Antigen And Control
Product CodeLKO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAntinuclear Antibody Immunological Test System.
CFR Regulation Number866.5100 [🔎]
Premarket Reviews
ManufacturerDecision
EUROIMMUN US
 
SUBSTANTIALLY EQUIVALENT
1
Recalls
Manufacturer Recall Class Date Posted
1
Euro Diagnostica AB
III Aug-23-2018
TPLC Last Update: 2019-04-02 20:22:52

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