(Box) Wondfo Strep A Throat Swab Test, CLIA WAIVED, 25/ Box, 20/Case

SKU: BB-SA01

Strep A Swab Test is a rapid chromatographic immunoassay for qualitative detection of group A streptococcal antigen from throat swab specimens. The test is intended for use as an aid in the diagnosis of group A streptococcal infection.

Contents: (25) Test Cassette, (1) Extraction Reagent A, (1) Extraction Reagent B, (25) Sterile Throat Swab, (1) Positive Control, (1) Negative Control, (1) Package Insert, (1) Procedure Card.

Easy to Use

External Control Included

FDA Approved and CLIA Waived

Description

Individually wrapped test strips

Revenue Stream

Preliminary Results While Patient Waits

Store at 4~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze. No Refrigeration Required

The test cassette/strip should be used within 1 hour after taking out from the sealed pouch.
Keep away from sunlight, moisture and heat.
The manufacturing date is printed on the outer box.

CPT Code: 87880QW

Technical Factors:

  • Sensitivity: 95.0% by comparing culture method
  • Results in 10 minutes

 

Catalog No. Item Format Sample Type Qualification
W039 Strep A
(self-testing)
cassette swab CE0123
CLIA WAIVED
Additional information
Weight 2 lbs
Dimensions 10 × 6 × 5 in
Brand

Wondfo

Item

Strep A

CLIA

CLIA Waived

Registration

FDA

Additional Info

Additional information

Certificate: ISO13485/ FDA/CE/ CLIA Waived.

Shipped from US Michigan.

Available in a case of 20 boxes, each box contains 25 Test.

Minimum order quantity: One Box.

Delivery: 4 days maximum form the order?s date.

Return is not accepted if case or bag is opened, or seal broken

Instruction of use