Treatment Table Performaâ„¢ 400 lbs. Weight Capacity 2001213960

Treatment Table Performaâ„¢ 400 lbs. Weight Capacity

Tissue Forceps Furst-Allis 10 Inch Length Surgical Grade Steel NonSterile Ratchet Lock Finger Ring Handle 5 X 6 Teeth 2001223482

Tissue Forceps Furst-Allis 10 Inch Length Surgical Grade Steel NonSterile Ratchet Lock Finger Ring Handle 5 X 6 Teeth

Antigen Detection Control Panel IntelliSwab® COVID-19 Rapid Test Pro Limit of Detection, Low Positive Level, Negative Level

$195.09
InteliSwab,REFERENCE PANEL, VISUAL KIT INTELISWAB F/COVID-19 TEST D/S, UOM (BX)
SKU
2001215561
Discontinued, See Alternate

Product Specifications

SLI Medical#1215561
Manufacturer #1001-0599
BrandIntelliSwab®
ManufacturerOrasure Technologies
Country of OriginUnited States
ApplicationVisual Reference Panel
For Use WithFor use with IntelliSwab COVID-19 Rapid Test Kit
HCPCSU0002
LevelsLimit of Detection
Product Dating Low Positive Level
Test Name Negative Level
Test TypeSLI Medical Acceptable Dating: we will ship >= 90 days
UNSPSC CodeCOVID-19 Rapid Test Pro
Antigen Test
41116205

Features

  • The InteliSwab® COVID-19 Rapid Test Pro is for use under the Food and Drug Administration’s Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 InteliSwab® COVID-19 Rapid Test Pro Visual Reference Panel contains: InteliSwab® COVID-19 Limit of Detection (1 device)
  • InteliSwab® COVID-19 Low Positive (1 device)
  • InteliSwab® COVID-19 Negative (1 device)
  • Instructions for Use Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
  • 42 U.S.C. §263a
  • that meet the requirements to perform moderate
  • high or waived complexity tests This test is authorized for use at the Point of Care (POC)
  • i.e.
  • in patient care settings operating under a CLIA Certificate of Waiver
  • Certificate of Compliance
  • or Certificate of Accreditation Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities in accordance with local
  • state
  • and federal requirements using appropriate LOINC and SNOMED codes
  • as defined by the Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC Positive results indicate that viral antigens have been detected
  • but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not exclude bacterial infection or coinfection with other viruses Negative results should be treated as presumptive and confirmation with a molecular assay
  • if necessary
  • for patient management
  • may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions
  • including infection control decisions Negative results should be considered in the context of an individual’s recent exposures
  • history and the presence of clinical signs and symptoms consistent with COVID-19 The InteliSwabâ„¢ COVID-19 Rapid Test Pro is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in POC settings
REFERENCE PANEL, VISUAL KIT INTELISWAB F/COVID-19 TEST D/S