-
,for, Item ID-
- #1186180
- Providers like you icon 10
- Abbott Rapid Dx North America LLC #195080
Antigen Test Control BinaxNOW™ COVID-19 Ag Positive Level 10 Swabs
CONTROL, COVID-19 AG BINAX NOW10 POS SWAB (10TEST/KT)
No Image
Features
- BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration’s 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, 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
- The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal (nares) swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms
- More …
Product Details Email
Product Specifications
McKesson # | 1186180 |
---|---|
Manufacturer # | 195080 |
Brand | BinaxNOW™ |
Manufacturer | Abbott Rapid Dx North America LLC |
Country of Origin | United States |
Application | Control |
For Use With | For use with BinaxNOW™ COVID-19 Ag Card |
Form | Swab |
Levels | Positive Level |
Product Dating | McKesson Acceptable Dating: we will ship >= 60 days |
Test Category | Respiratory |
Test Name | COVID-19 Ag |
Test Type | Antigen Test |
UNSPSC Code | 41116145 |
Volume | 10 Swabs |
Features
- BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration’s 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, 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
- The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal (nares) swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection 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
More Information
- BinaxNOW COVID-19 Ag Card FDA EUA Letter
- BinaxNOW COVID-19 Ag Card Insert
- BinaxNOW COVID-19 Ag Card Procedure
- BinaxNOW COVID-19 Ag Card Healthcare Providers Fact Sheet
- BinaxNOW COVID-19 Ag Card Healthcare Providers Fact Sheet Spanish
- BinaxNOW COVID-19 Ag Card Patients Fact Sheet
- BinaxNOW COVID-19 Ag Card Patients Fact Sheet Spanish
- NAVICA System Sell Sheet
Professionals Also Viewed
-
,for, Item ID-
- #1113580
- Providers like you icon 265
- McKesson Brand #900-501MCK
- Used by professionals in the verification of the precision and accurac …
- 60-day open-vial stability
- Non-biohazardous
-
,for, Item ID-
- #1113579
- Providers like you icon 251
- McKesson Brand #900-503MCK
- Used by professionals in the verification of the precision and accurac …
- 60-day open-vial stability
- Non-biohazardous
-
,for, Item ID-
- #1113581
- Providers like you icon 199
- McKesson Brand #900-502MCK
- Used by professionals in the verification of the precision and accurac …
- 60-day open-vial stability
- Non-biohazardous
-
,for, Item ID-
- #763082
- Providers like you icon 503
- Hemocue #171003002
- Each Eurotrol Hemotrol control has an open-vial stability of 30 days a …
- Stable for 18 months from the date of manufacture if stored unopened i …
- Hemotrol controls may be used with Hemocue, Stat-Site, HemoPoint and H …