Phase Scientific America# IND-HG-STREP-25PPK Strep A Throat Swab Indicaid Rapid Test Kit 25 Tests CLIA Waived 25/KT 54KT/CS Specifications Items Per Box 25 Specimen Type Throat Swab Result Time 5 Minutes Accuracy Sensitivity 97.1%, Specificity 99.4% Test Components 25 Test strips, 25 Sterile swabs, 25 Disposable extraction tubes, 1 Reagent A, 1 Reagent B, 1 Positive Control, 1 Negative Control, 1 Instructions for Use FDA 510(k) Yes Intended Use The Rapid Strep A Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection. All negative tests should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
Phase Scientific America# IND-HG-STREP-25PPK Strep A Throat Swab Indicaid Rapid Test Kit 25 Tests CLIA Waived 25/KT 54KT/CS Specifications Items Per Box 25 Specimen Type Throat Swab Result Time 5 Minutes Accuracy Sensitivity 97.1%, Specificity 99.4% Test Components 25 Test strips, 25 Sterile swabs, 25 Disposable extraction tubes, 1 Reagent A, 1 Reagent B, 1 Positive Control, 1 Negative Control, 1 Instructions for Use FDA 510(k) Yes Intended Use The Rapid Strep A Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection. All negative tests should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
