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Mrl Diagnostics

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K000238 HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GLGC2000-04-14 View
510(k) K993754 HSV-1 ELISA IGG, MODEL EL0910GMXJ2000-02-09 View
510(k) K993724 HSV-2 ELISA IGG, MODEL EL0920GMYF2000-02-01 View
510(k) K971006 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)LSR1998-06-01 View
510(k) K971007 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)LSR1998-06-01 View
510(k) K946353 EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAYLLM1995-07-21 View
510(k) K931520 EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODYLJN1994-04-26 View
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