NOWDiagnostics First To Know™ Rapid Syphilis Test — FDA Cleared | CLIA Waived | OTC | 15-Min Result | 25 Tests/Box

The NOWDiagnostics First To Know™ Rapid Syphilis Test is the first and only FDA-cleared, CLIA-waived, over-the-counter point-of-care syphilis test cleared for self-collection. Using a simple fingerstick with a blood drop applied directly to the device — no sample separation or prep needed — results are delivered in just 15 minutes. Qualitative result (positive = test line). Intended for symptomatic or asymptomatic patients with no prior history of syphilis infection. 25 tests per box.

As a major North American medical supply distributor, Big Ben Medical Supplies offers competitive bulk pricing on rapid diagnostic tests for hospitals, clinics, urgent care centers, public health programs, and multi-location healthcare organizations.

Key Features

• ✅ FDA Cleared & CLIA Waived: Approved for point-of-care and OTC use
• ✅ First OTC Syphilis POC Test: Only FDA-cleared product for self-collection and OTC detection
• ✅ Touch, Tap & Test: Fingerstick blood drop directly on device — no separation or sample prep
• ✅ 15-Minute Result: Fast, actionable results at the point of care
• ✅ Qualitative Result: Positive = test line; easy to read by any user
• ✅ 25 Tests Per Box

Product Specifications

• Brand: NOWDiagnostics, Inc.
• Test Type: Rapid syphilis antibody test
• Sample Type: Fingerstick whole blood (self-collected)
• Result Time: 15 minutes
• CLIA Status: CLIA waived
• Rx Status: OTC (over-the-counter)
• CPT Code: 86780
• Quantity per Box: 25 tests

Documents

• Instructions for Use (English & Spanish) (PDF)
• FDA Authorization (PDF)