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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameQuest International SeraQuest CMV IgG  {Hyperion HyPrep Plus} (manual calculations)
Document NumberK954191
Analyte NameCytomegalovirus antibodies
Analyte SpecialtyGeneral Immunology
ComplexityHIGH
Effective Date12/13/1996
Device Classification Name enzyme linked immunoabsorbent assay, cytomegalovirus
510(k) Number K954191
Device Name SERAQUEST CMV IGG
Original Applicant
QUEST INTL., INC.
1938 n.e. 148th terr.
north miami,  FL  33181
Original Contact robert a cort
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received09/06/1995
Decision Date 02/23/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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