Healgen® Rapid Strep A Antigen Test – 25 Tests/Box (510(k) Cleared, CLIA-Waived)

Healgen® Rapid Strep A Antigen Test – 25 Tests/Box (510(k) Cleared, CLIA-Waived)

Availability:
Ships same business day if by 3pm EST. SIGNATURE required delivery.

- CLIA Waived Strep Throat Test
- FDA 510K Cleared
- Purchase in bulk or small quantities to meet your specific volume needs
- Join our flexible auto-ship program to help make reordering easy
- The expiration date is typically 11 months or longer of available shelf life
- For large orders please email Admin@medicaldistributiongroup.com or call (727)744-2967


For the Healgen Strep test package CLIA Waived insert please click the icon below:


The Healgen® Rapid Strep A Antigen Test is a professional-use diagnostic kit designed for the qualitative detection of Group A Streptococcal (GAS) antigens in throat swab specimens. With 510(k) clearance and CLIA-waived status, this test offers a reliable, rapid solution for identifying strep throat infections and guiding patient management and antibiotic stewardship.

Each box contains 25 ready-to-use test units—all components needed for throat-swab testing are included, with no extra equipment required. Designed for ease of use, the cassette format provides clear visual results in approximately 5 minutes, enabling efficient patient throughput and improved clinical decision-making.

This test kit is ideal for:

Primary care and urgent care clinics

Retail pharmacies offering in-store testing services

School health programs and occupational health screening

Walk-in clinics and telehealth diagnostics

Multi-user labs seeking a no-instrument rapid option

Key features:

510(k) cleared & CLIA-waived for ease of use and regulatory compliance

Delivers results in ~5 minutes—great for fast triage & patient turnover

Cassette format—compact, no extra instrumentation required

Kit includes 25 complete test units (swabs, extraction tubes, cassettes)

Supports antimicrobial stewardship by enabling rapid, on-site diagnosis

Suggested kit contents include: 25 test cassettes, 25 sterile throat swabs, 25 disposable extraction tubes, extraction reagents, and illustrated instructions for use. Storage is at room temperature; shelf-life is typically 24 months from manufacture (verify lot-specific label). Use only with human throat swab specimens; follow the Instructions for Use (IFU) for specimen collection, processing steps, and result interpretation.

Clinical performance: In independent studies, this test demonstrated > 96% sensitivity and > 99% specificity for GAS antigen detection (check your current lot IFU for exact values). Sample processing is straightforward and can be performed in low-complexity (“waived”) settings, per CLIA guidelines.

Package includes: One box containing 25 tests and all consumables required. Each test is for prescription or professional use only; not intended for over-the-counter (OTC) home use.

Important Regulatory & Usage Notes:

For professional use only — not intended for home self-testing.

CLIA-waived status means the test can be performed in qualified waived settings under the Clinical Laboratory Improvement Amendments (CLIA).

Perform only on throat swab specimens from humans; results outside intended use may be invalid.

Always follow the full Instructions for Use, observe expiration dates, and maintain proper storage conditions.

Rapid antigen tests help support, but do not replace, clinical judgment; negative results in symptomatic patients may still require confirmatory culture or molecular testing.