CLIA - Clinical Laboratory Improvement Amendments

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33 records meeting your search criteria returned - Test System / Manufacturer immunostics

New Search Export to Excel | Help | Download Files Document Analyte Analyte Specialty Complexity Effective Date Immunostics Detector H. Pylori  {H. Pylori Antibodies} (Serum/Plasma) K980798 Helicobacter Pylori Antibodies General Immunology MODERATE 05/16/2007 Immunostics Detector H. pylori WB  {H. pylori Antiboby Test} (For whole blood) K980798 Helicobacter Pylori Antibodies General Immunology WAIVED 05/16/2007 Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test   K060463 Fecal Occult Blood General Chemistry WAIVED 06/15/2006 Immunostics Immuno hCG Detector   K041728 Urine hCG By Visual Color Comparison Tests Endocrinology WAIVED 02/15/2005 Immunostics Immuno hCG Detector Combi   K041728 Urine hCG By Visual Color Comparison Tests Endocrinology WAIVED 02/15/2005 Immunostics Immuno hCG Detector Combi   K041728 hCG, Serum, Qualitative Endocrinology MODERATE 02/15/2005 Immunostics Immuno hCG Detector Stix Test   K041728 Urine hCG By Visual Color Comparison Tests Endocrinology WAIVED 02/15/2005 IMMUNOSTICS DETECTOR STREP A DIRECT   K023766 Streptococcus, Group A Bacteriology WAIVED 06/28/2004 IMMUNOSTICS RUBELLACOL  (qualitative) K031490 Rubella Antibodies General Immunology HIGH 11/03/2003 IMMUNOSTICS RUBELLACOL  (quantitative) K031490 Rubella Antibodies General Immunology HIGH 11/03/2003