- #1231901
- 382
- Abbott Rapid Dx North America LLC #192000B5G6
再保险spiratory Test Kit ID NOW™ COVID-19 2.0 24 Tests per Kit CLIA Waived
PROMO PKG, ID NOW 2.0 COVID-19BUY 5 GET 6 (6/CS) D/S
Features
- ID NOW™ COVID-19 2.0, Buy 5, Get 6 Promo Pack (i.e. 6 kits total)
- ID NOW COVID-19 2.0 Assay is for use under an Emergency use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
- To utilize the ID NOW COVID-19 2.0 assay, a software upgrade to version 7.0.0.20 is required for all instruments; the software upgrade is backward compatible to support use of ID NOW COVID-19, Influenza A & B 2, Strep A 2, and RSV inventory
- More …
Product Details Email
Product Specifications
McKesson # | 1231901 |
---|---|
Manufacturer # | 192000B5G6 |
Brand | ID NOW™ |
Manufacturer | Abbott Rapid Dx North America LLC |
Country of Origin | United States |
Application | 再保险spiratory Test Kit |
CLIA Classification | CLIA Waived |
CLIA Classified | CLIA Waived |
Contents 1 | But 5, Get 6 Test Kits - Each Kit Contains: Test Bases, Sample Receivers, Transfer Cartridges, Patient Swabs, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions |
For Use With | For ID Now™ Instrument US |
Number of Tests | 24 Tests per Kit |
Purchase Program Type | Promotion |
再保险ading Type | Machine Read |
Sample Type | Nasal Swab / Nasopharyngeal Swab Sample |
Specialty | Molecular |
Technology | Isothermal Nucleic Acid Amplification Technology (NAAT) |
Test Format | Test Device Format |
Test Kit Type | Rapid |
Test Name | COVID-19 2.0 |
Test Type | Molecular Diagnostic |
Time to Results | 12分钟的结果 |
UNSPSC Code | 41116129 |
Features
- ID NOW™ COVID-19 2.0, Buy 5, Get 6 Promo Pack (i.e. 6 kits total)
- ID NOW COVID-19 2.0 Assay is for use under an Emergency use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
- To utilize the ID NOW COVID-19 2.0 assay, a software upgrade to version 7.0.0.20 is required for all instruments; the software upgrade is backward compatible to support use of ID NOW COVID-19, Influenza A & B 2, Strep A 2, and RSV inventory
- Product ships with minimum 30 days dating
- ID NOW COVID-19 2.0 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms
- 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 high, moderate or waived complexity tests
- The ID NOW COVID-19 2.0 assay 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
- 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
- Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities
- Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be confirmed with a different authorized or cleared molecular test in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests
- 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/or epidemiological information
- Materials required but not provided: ID NOW Instrument, Nasopharyngeal Swabs
- To utilize the ID NOW COVID-19 2.0 assay, a software upgrade to version 7.0.0.20 is required for all instruments; the software upgrade is backward compatible to support use of ID NOW COVID-19, Influenza A & B 2, Strep A 2, and RSV inventory
- ID NOW COVID-19 2.0 is intended for use by trained operators who are proficient in performing tests using the ID NOW Instrument
- Positive results as early as 6 minutes, negative results in 12 minutes
More Information
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