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Multiple infectious organism/newborn TORCH screen IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to organisms in a clinical specimen, as part of an antenatal or newborn infection TORCH screen. The assay is intended to detect infection by multiple organisms that include Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV), Herpes simplex virus 1 (HSV1), Herpes simplex virus 2 (HSV2), human immunodeficiency virus 1 (HIV1), measles virus and/or Treponema pallidum, and sometimes additional organisms.
GUDID devices
7
Last updated
2024-08-12 08:32:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850041090009ACCURUN®Lgc Clinical Diagnostics, Inc.2000-01012024-08-02
00850041090016ACCURUN®Lgc Clinical Diagnostics, Inc.2010-00232024-08-02
00850041090023ACCURUN®Lgc Clinical Diagnostics, Inc.2015-02402024-08-02
00850041090030ACCURUN®Lgc Clinical Diagnostics, Inc.2000-01022024-08-02
05055273216400SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)RANDOX LABORATORIES LIMITEDSR103472020-06-12
05055273216417SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +)RANDOX LABORATORIES LIMITEDSR103482020-06-12
05055273216424SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +)RANDOX LABORATORIES LIMITEDSR103492020-06-12