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Rapid Test Kit Solana® Molecular Diagnostic SARS-CoV-2 Nasal Swab / Nasopharyngeal Swab Sample 48 Tests

$2,778.80
TEST KIT, SARS-COV-2 ASSAY LYOPHILIZED NP SWAB (48/KT) D/S
SKU
1001209945

Product Specifications

SLI Medical #1209945
Manufacturer #M960
BrandSolana®
ManufacturerQuidel
Country of OriginUnited States
ApplicationRapid Test Kit
Contents 1(48) Tests
For Use With Controls
HCPCS (50) Nasopharyngeal Swabs
Number of Tests (50) Universal Transport Media
Product DatingFor use with Solana Instrument
Reading TypeU0002
Sample Type48 Tests
Storage RequirementsSLI Medical Acceptable Dating: we will ship >= 90 days
Test FormatMachine Read
Test MethodNasal Swab / Nasopharyngeal Swab Sample
Test NameRequires Refrigeration
Test TypeTube Format
Time to ResultsIsothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) Assay
UNSPSC CodeSARS-CoV-2
Molecular Diagnostic
25 Minute Results
41116144

Features

  • Solana SARS-CoV-2 Assay is for use under an FDA Emergency Use Authorization: https:www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
  • 42 U.S.C. §263a
  • to perform high or moderate complexity tests The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status Positive results do not rule out bacterial infection or co-infection with other viruses Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations
  • patient history
  • and epidemiological information The Solana SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Solana SARS-CoV-2 Assay and/or the Solana Instrument The assay consists of two major steps: (1) specimen preparation
  • and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase — Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument
TEST KIT, SARS-COV-2 ASSAY LYOPHILIZED NP SWAB (48/KT) D/S
Additional Information
Product NameRapid Test Kit Solana® Molecular Diagnostic SARS-CoV-2 Nasal Swab / Nasopharyngeal Swab Sample 48 Tests
SKU1001209945
Price$2,778.80
Weight5.00
Featured ProductNo
Manufacturer SkuM960
UOMKT
ManufacturerSolana®
Short DescriptionTEST KIT, SARS-COV-2 ASSAY LYOPHILIZED NP SWAB (48/KT) D/S