FIAX TEST FOR ANTI-RUBELLA ANTIBODY

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS

The following data is part of a premarket notification filed by Idt, A Division Of Whittaker M.a. Bioproducts with the FDA for Fiax Test For Anti-rubella Antibody.

Pre-market Notification Details

Device IDK772219
510k NumberK772219
Device Name:FIAX TEST FOR ANTI-RUBELLA ANTIBODY
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-05
Decision Date1978-01-20

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