- Rapid qualitative detection of Streptococcus pyogenes (Group A Strep) from throat swab specimens.
- Easy flip step—no pipetting; single-use extraction capsules.
- Visual cassette read with color-coded control/test lines; results in 5 minutes.
- CLIA-waived; packaged as 25 tests per kit for professional in vitro diagnostic use.
- Reported sensitivity 96.2% and specificity 98.7% (manufacturer listing).
- SKU:
- 1127458
- Contents:
- (25) Test Cassettes, (25) Sterile Swabs, (25) Extraction Reagent Capsules, Positive Control, Negative Control, Instructions for Use, Procedure Card
- Latex Free Indicator:
- Not Made with Natural Rubber Latex
- QTY Per Sell:
- 1
- UPC:
- 612479242869
- GTIN:
- 00612479244122
- Number of Tests:
- 25 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Throat / Tonsil Saliva Sample
- Key Features:
- Flip-step; no pipetting
- Single-use extraction capsules
- 5-minute visual result
- Color-coded test/control lines
- Technical Specifications:
- Format: Cassette, lateral flow
- Tests per kit: 25
- Readout: Visual
- Performance:
- Manufacturer-listed sensitivity 96.2% and specificity 98.7% (as provided on product listing).
- Regulatory Information:
- CLIA-waived; For in vitro diagnostic use; Professional/laboratory use only.
- Packaging Details:
- Packaged 1 kit pouch, 25 pouches per box (per product listing).
- Test Method:
- Lateral flow immunoassay (rapid cassette).
- Country of Origin:
- United States
- Product Dating / Ship:
- McKesson ships with acceptable dating >= 90 days (per McKesson product spec).
- Shelf Life:
- Not specified on McKesson product listing.
- Manufacturer Link:
- McKesson product listing (manufacturer/distributor page).
