Product Specifications
| Specification | Details |
|---|---|
| Manufacturer / Brand | Princeton BioMeditech Corporation |
| Manufacturer # / SKU | 36025 |
| Brand Line | Status Flu A & B |
| Product Type | Rapid Antigen Test Kit – Influenza A & B |
| Test Method | Lateral flow immunoassay, cassette format |
| Number of Tests | 25 tests per box |
| Sample Types | Nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash |
| CLIA Classification | CLIA waived for nasal and nasopharyngeal swab specimens; moderate complexity for aspirate/wash |
| Time to Results | Approximately 10–15 minutes |
| Result Type | Qualitative (positive/negative for influenza A and/or B antigens) |
| Target Analytes | Influenza A and B nucleoprotein antigens |
| Kit Contents | 25 Status Flu A & B test devices, extraction reagent capsules, sterile swabs, positive control, negative control, instructions |
| Controls Included | External positive and negative controls included |
| Storage Conditions | Store at room temperature within range specified on the kit; do not freeze; keep pouches sealed until use |
| Shelf Life | Use by expiration date printed on kit packaging |
| Packaging / Sold As | 25-test kit (box) |
| Bulk Packaging / Sold As | N/A |
| Country of Origin | United States |
| Intended Use | In vitro rapid qualitative detection of influenza A and B viral antigens from respiratory specimens in symptomatic patients; for professional use only |
| UNSPSC Code | 41116144 |
Key Features
-
Rapid point-of-care detection of influenza A and B using nasal or nasopharyngeal specimens.
-
Results in approximately 10–15 minutes, supporting quick treatment decisions and triage.
-
CLIA waived for swab specimens, making it suitable for many outpatient and office-based settings.
-
Cassette format with onboard extraction reagent capsules for a simplified workflow.
-
External positive and negative controls in each kit to support quality control programs.
-
Room-temperature storage and long shelf life, ideal for stocking throughout flu season.
