-
,for, Item ID-
- #1233420
- Providers like you icon 17
- Abbott Rapid Dx North America LLC #IDNOW15C
Respiratory Test Kit ID NOW™ COVID-19 2.0 15 X 24 Tests CLIA Waived
PROMO PKG, ID NOW 15COVID KITS& INSTR D/S
Features
- 15 Covid kits + ID NOW instrument
- 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
- Product ships with minimum 30 days dating
- More …
Product Details Email
Product Specifications
McKesson # | 1233420 |
---|---|
Manufacturer # | IDNOW15C |
Brand | ID NOW™ |
Manufacturer | Abbott Rapid Dx North America LLC |
Country of Origin | United States |
Application | Respiratory Test Kit |
CLIA Classification | CLIA Waived |
CLIA Classified | CLIA Waived |
Contents 1 | ID Now Instrument (NAT024), (15) ID NOW COVID-19 2.0 Test Kits (EUA) (192000) |
For Use With | For ID Now™ Instrument US |
Number of Tests | 15 X 24 Tests |
Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
Purchase Program Type | Starter Kit |
Reading Type | Machine Read |
Sample Type | Nasal Swab / Nasopharyngeal Swab Sample |
Specialty | Molecular |
Technology | Isothermal Nucleic Acid Amplification Technology (NAAT) |
Test Format | Cartridge Format |
Test Kit Type | Standard |
Test Name | COVID-19 2.0 |
Test Type | Molecular Diagnostic |
Time to Results | 12 Minute Results |
UNSPSC Code | 41116144 |
Features
- 15 Covid kits + ID NOW instrument
- 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
- Product ships with minimum 30 days dating
- 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 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
- 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
Professionals Also Viewed
-
,for, Item ID-
- #1076728
- Providers like you icon 7,390
- McKesson Brand #181-36025
- Rapid qualitative test that detects Influenza type A and type B antige …
- Color-coded control swab packaging for easy positive/negative identifi …
- Results in under 15 minutes
-
,for, Item ID-
- #951316
- Providers like you icon 5,936
- McKesson Brand #5003
- A rapid test for the qualitative detection of Strep A antigen in throa …
- CLIA waived and easy to use
- Contents: 25 Dipsticks (in sealed pouches), Disposable extraction test …
-
,for, Item ID-
- #951312
- Providers like you icon 4,867
- McKesson Brand #4999
- A rapid test for the qualitative detection of Strep A antigen in throa …
- CLIA waived and easy to use
- Contents: 50 Dipsticks (2 vials of 25), Disposable extraction test tub …
-
,for, Item ID-
- #1127458
- Providers like you icon 500
- McKesson Brand #181-34125
- A rapid test for the qualitative detection of Strep A antigen in throa …
- Easy-to-use flip step eliminates need for pipetting
- Fast, accurate detection of Group A Strep with walk-away convenience