510(k) K093784

ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM by Zeus Scientific, Inc. — Product Code OPM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 16, 2010
Date Received: December 9, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Device Class: Class II
Regulation Number: 866.3510
Review Panel: MI
Submission Type

The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors.

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