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Syphilis Health Check™ Syphilis Screen Infectious Disease Immunoassay Sexual Health Test Kit #1001-0698

Syphilis Health Check™

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Syphilis Health Check™ Syphilis Screen Infectious Disease Immunoassay Sexual Health Test Kit #1001-0698
  • Test for syphilis and receive results in 10 minutes.
  • CLIA moderately complex – whole blood, serum or plasma; CLIA-waived for fingerstick whole blood.
  • Kit contains 20 test devices, 20 fixed-volume pipettes, 5 mL premixed diluent, IFU and quick reference guide.
SKU:
1027323
Contents:
Test Devices, Pipettes, Diluent, Instructions for Use
QTY Per Sell:
1
Number of Tests:
20 Tests
Reading Type:
Visual Read
Sample Type:
Whole Blood / Serum / Plasma Sample
Regulatory Information:
FDA 510(k) cleared; CLIA-waived for fingerstick whole blood; CLIA-moderate for venous whole blood/serum/plasma.
Sensitivity / Specificity:
Sensitivity ~98.0%; Specificity ~97.2%.
Intended Use:
Qualitative rapid treponemal antibody test to aid syphilis diagnosis; not for blood donor screening.
CPT / Reimbursement:
CPT code 86780QW (reimbursable when appropriate).
Shelf Life:
30-month shelf life from manufacture.
Storage Instructions:
Store 2–30°C (36–86°F). Do not freeze. Keep sealed until use.
Packaging Details:
  • 20 cassettes per box
  • 20 pipettes per box
  • 1 x 5 mL buffer bottle
    • Warnings and Contraindications:
  • For professional use only (not a self-test)
  • Not for blood/plasma donor screening
  • Read results at 10 minutes (no later than 15)
    • Manufacturer / Distributor Link:
    Verséa Diagnostics product page; Diagnostics Direct trademark holder.
    Country of Origin:
    Manufactured in France (VedaLab) for Diagnostics Direct / distributed in US by Verséa/OraSure/Diagnostics Direct.
    SKU:
    1027323
    Contents:
    Test Devices, Pipettes, Diluent, Instructions for Use
    QTY Per Sell:
    1
    Number of Tests:
    20 Tests
    Reading Type:
    Visual Read
    Sample Type:
    Whole Blood / Serum / Plasma Sample
    ic__sync_id:
    1
    ic__id:
    1241
    Regulatory Information:
    FDA 510(k) cleared; CLIA-waived for fingerstick whole blood; CLIA-moderate for venous whole blood/serum/plasma.
    Sensitivity / Specificity:
    Sensitivity ~98.0%; Specificity ~97.2%.
    Intended Use:
    Qualitative rapid treponemal antibody test to aid syphilis diagnosis; not for blood donor screening.
    CPT / Reimbursement:
    CPT code 86780QW (reimbursable when appropriate).
    Shelf Life:
    30-month shelf life from manufacture.
    Storage Instructions:
    Store 2–30°C (36–86°F). Do not freeze. Keep sealed until use.
    Packaging Details:
  • 20 cassettes per box
  • 20 pipettes per box
  • 1 x 5 mL buffer bottle
    • Warnings and Contraindications:
  • For professional use only (not a self-test)
  • Not for blood/plasma donor screening
  • Read results at 10 minutes (no later than 15)
    • Manufacturer / Distributor Link:
    Verséa Diagnostics product page; Diagnostics Direct trademark holder.
    Country of Origin:
    Manufactured in France (VedaLab) for Diagnostics Direct / distributed in US by Verséa/OraSure/Diagnostics Direct.