Strep A Respiratory Test Kit Status Strep A Test 25 Tests CLIA Waived by LifeSign ID 34125

196-1-3425
      
Stock Est. Shipping Date: 8th May 2025 ⓘ

Strep A Respiratory Test Kit Status Strep A Test 25 Tests CLIA Waived
Sold by: KT OF 25

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Rally #196-1-3425
LifeSign #34125
Status Strep A Flip (25/KT)

Rapid Test, Strep A, Throat swab, Immunochromatographic Assay, CLIA Complexity Waived, Rx Only

Features
  • CLIA Waived
  • Single Use Reagent Capsules
  • Positive Results In 5 Minutes
  • Sensitivity 96%, Specificity 99%
  • No Counting Reagent Drops – Fewer Steps For Greater Accuracy
The Status® Strep A Flip is a rapid immunochromatographic assay for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in physician’s offices, hospitals and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.

Important Notes
  • Product is non-returnable; please make sure it is the right product before ordering.
  • For In Vitro Diagnostic Use
  • For Rx Use Only
For the State of California:
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

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Rally #196-1-3425
Manufacturer #34125
BrandStatus
ManufacturerLifeSign / Princeton BioMeditech
Country of OriginUnited States
ApplicationRespiratory Test Kit
CLIA ComplexityCLIA Waived
Number of Tests25 Tests
Reading TypeVisual Read
Sample TypeThroat Swab Sample
Test FormatCassette Format
Test Kit TypeRapid
Test NameStrep A Test
Test TypeImmunochromatographic Assay
Time to Results5 Minute Results
Sensitivity96%
Specificity99%
UNSPSC Code41116129
Storage Temperature2-30°C (35-86°F)

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Configurations
Product ID Description Number of Tests
34125 Status Strep A Flip (cassettes) 25
34130 Status Strep A Strip (pouch) 30
34250 Status Strep A Plus (canister-strips) 50
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- Materials and Reagents Provided -

Each Status® Strep A Flip test kit contains enough reagents and materials for 25 tests (Item No. 34125).

  • Status® Strep A Flip test device: Contains a membrane coated with rabbit anti-group A streptococcus antibody for the test line and a second control antibody, and a conjugate pad impregnated with the rabbit-Strep A antibody dye complex in a protein matrix containing 0.1% sodium azide.
  • Single-use Extraction Reagent Capsules with dual chambers, each chamber containing Extraction Reagent A (sodium nitrite solution) and Extraction Reagent B (dilute phosphoric acid solution). Warning: Irritant. Avoid contact with eyes or skin.
  • Positive Control (1 mL): Extracted (non-infective) Group A Streptococcus antigen in phosphate buffered saline containing 0.1% sodium azide.
  • Negative Control (1 mL): Extracted (non-infective) Group B Streptococcus antigen in phosphate buffered saline containg 0.1% sodium azide.
  • Throat Swabs: Rayon swab with plastic shaft (use only the swabs supplied).
  • Instructions for Use
  • Procedure Card
- Materials Required but Not Provided -

  • Timer
  • Latex gloves
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