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  • Healgen® Rapid Strep-A Antigen Test, FDA 510(k) CLIA Waived, Kit Contents
  • Healgen® Rapid Strep-A Antigen Test, FDA 510(k) CLIA Waived # GCSTR-501Ca
  • Healgen® Rapid Strep-A Antigen Test, FDA 510(k) CLIA Waived, 25/Box

    • Healgen® Rapid Strep-A Antigen Test, FDA 510(k) CLIA Waived, 25/Box

    Healgen Scientific

    $65.00
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    SKU:
    GCSTR-501Ca
    [{"type":"fixed","min":4,"max":7,"discount":{"formatted":"$61.75","value":61.75,"currency":"USD"}},{"type":"fixed","min":8,"max":0,"discount":{"formatted":"$58.50","value":58.5,"currency":"USD"}}]
    Quantity Price per Box Per Each
    Buy 1 - 3 $65.00 Per Each $2.60
    Buy 4 - 7 $61.75 $2.47
    Buy 8 or above $58.50 $2.34
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    Product Description

    Healgen® Rapid Strep A Antigen Test

    FDA 510(k) Cleared · CLIA Waived · 25 Tests/Box

    • Qualitative detection of Group A Streptococcal antigen from throat swab.
    • ~5 minute results, cassette format, no instrument required.
    • Includes external positive & negative controls for QC.
    510(k): K212623 CLIA Waived Cassette Throat Swab 25 Tests/Box Room Temp Storage
    ~5 min
    Time to Results
    96.5%
    Sensitivity
    99.5%
    Specificity
    Overview

    The Healgen® Rapid Strep A Antigen Test (REF GCSTR-501Ca) is a lateral flow immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens. It is FDA 510(k) cleared (K212623) and CLIA Waived for point-of-care use.

    • Intended use: Aid in the diagnosis of Group A Streptococcal infection.
    • Format: Cassette; specimen: human throat swab.
    • No additional instrumentation required.
    Kit Contents (25 Tests)
    • 25 test cassettes
    • 25 sterile throat swabs
    • 25 extraction tubes + tube holders
    • Extraction reagents:
      • Reagent A (10 mL): 2.0 M Sodium Nitrite
      • Reagent B (10 mL): 0.2 M Acetic Acid
    • External controls: Positive (non-viable Strep A; 0.05% ProClin™ 300) and Negative (non-viable Strep C; 0.05% ProClin™ 300)
    • Instructions for Use + Quick Reference Guide
    Specifications
    Catalog / REF GCSTR-501Ca
    Time to Results Approximately 5 minutes
    Sensitivity / Specificity 96.5% / 99.5%
    Shelf Life 24 months from date of manufacture
    Storage Room temperature
    CLIA Status Waived
    Regulatory FDA 510(k) cleared; 510(k) #: K212623
    Clinical & Operational Notes
    • Negative results should be confirmed by throat culture when clinical suspicion remains.
    • Use only by healthcare professionals in settings operating under a CLIA Certificate of Waiver, Compliance, or Accreditation.
    • Read the package insert (IFU) prior to use; follow all quality control procedures.
    Ordering & Availability:
    Ships from U.S. warehouse. Professional, institutional, and governmental customers only.

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