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Healgen® Rapid Strep A Antigen Test – CLIA Waived, FDA Cleared – 25 Tests/Box

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SKU:
GCSTR-501Ca
MPN:
GCSTR-501Ca
Availability:
Note: This product is intended for use by healthcare professionals or facilities operating under a CLIA Certificate of Waiver, Compliance, or Accreditation. Not for at-home or over-the-counter use.

Bulk discount rates

Below are the available bulk discount rates for each individual item when you purchase a certain amount

Quantity Per Item
1 - 3 $59.75
4+ $57.25
  • Healgen® Rapid Strep A Antigen Test – CLIA Waived, FDA Cleared – 25 Tests/Box | Item # GCSTR-501Ca
  • Healgen® Rapid Strep A Antigen Test – CLIA Waived, FDA Cleared – 25 Tests/Box | Item # GCSTR-501Ca
  • Healgen® Rapid Strep A Antigen Test – CLIA Waived, FDA Cleared – 25 Tests/Box | Item # GCSTR-501Ca
$59.75
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Description

Healgen® Rapid Strep A Antigen Swab Test Kit – CLIA Waived – 25 Tests/Box

The Healgen® Rapid Strep A Antigen Test is a CLIA-waived diagnostic kit designed for the fast, accurate detection of Group A Streptococcus (Strep A) antigens from human throat swab specimens. Ideal for use in doctor’s offices, urgent care clinics, pharmacies, and other point-of-care settings, this rapid test delivers clear results in just 5 minutes—helping clinicians diagnose and treat strep throat efficiently.

FDA 510(k) cleared and CE-IVDD certified, this strep throat test kit meets U.S. regulatory standards and includes everything needed to perform 25 individual tests. No additional equipment or instruments are required.

Note: This product is intended for use by healthcare professionals or facilities operating under a CLIA Certificate of Waiver, Compliance, or Accreditation. Not for at-home or over-the-counter use.

Why Choose the Healgen Rapid Strep A Test?

  • Fast Results: Results in approximately 5 minutes
  • High Accuracy: Sensitivity of 96.5%, Specificity of 99.5%
  • CLIA Waived: Approved for use in non-laboratory settings
  • Easy to Use: No special instruments or training required
  • Long Shelf Life: 24 months from date of manufacture
  • Reliable: Includes external positive and negative controls

Complete Kit Includes:

  • 25 Rapid Test Cassettes
  • 25 Sterile Throat Swabs
  • 25 Disposable Extraction Tubes
  • Reagent A (10 mL): 2.0 M Sodium Nitrite
  • Reagent B (10 mL): 0.2 M Acetic Acid
  • 1 mL Positive Control: Non-viable Strep A, 0.05% ProClin™ 300
  • 1 mL Negative Control: Non-viable Strep C, 0.05% ProClin™ 300
  • Tube Holders, Instructions for Use, and Quick Reference Guide

Specifications:

  • Test Format: Lateral flow cassette
  • Sample Type: Human throat swab
  • Result Time: ~5 minutes
  • Storage: Room temperature (no refrigeration needed)

Whether you're screening for sore throat symptoms or confirming a bacterial infection, the Healgen® Rapid Strep A Test offers a dependable solution that supports antibiotic stewardship and enhances patient satisfaction.

Buy online today from UScreenTests.com—your trusted source for CLIA-waived rapid diagnostic test kits.

Healgen Rapid Strep-A Antigen Swab Test Kit Procedure

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Additional Information

Per Each:
25
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