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InBios International, Inc. Strep A RespiraDX™ Rapid Test
SDP

Catalog No. 21403149
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21-403-149 Swab
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Catalog No. 21-403-149 Supplier InBios International, Inc. Supplier No. RSTP25
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Description

The Strep A RespiraDX™ Rapid Test is a rapid chromatographic immunoassay.

Strep A RespiraDX™ Rapid Test is for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

  • US FDA 510(k) cleared for in vitro diagnostic use
  • CLIA-Waived for Point-of-Care use
  • Sensitivity: 96.5%, Specificity: 99.5%
  • External positive and negative controls included
  • Room-temperature storage

Specifications

CE Marker No
Clia Complexity Waived
Detectable Analytes Streptococci (Group A)
DoA Calibrators No
Type Rapid Test
Disposable Single-use
Form Swab
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