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BinaxNOW 40 Pack COVID-19 AgCARD Test

$320.00

CLIA Waived, 40 Tests / BOX, 1 Reagent Bottle

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Description

Product Details
Brand: BinaxNOW
MPN : 195-000
Manufacturer: Abbott Laboratories
Weight: 2 lbs

Description Of Our BinaxNOW™ 40 Pack COVID-19 Ag Card

For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only | MPN 195-000

Performance Data Submitted To The FDA By Abbott:

  • Sensitivity: 97.1%
  • Specificity: 98.5%

The BinaxNOW™ COVID-19 Ag Card 40 Pack Box (195-000) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Negative results should be treated as presumptive, 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.

The BinaxNOW™ COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW™ COVID-19 Ag Card is only for use under the Food and Drug Administration’s EUA.

Abbott BinaxNow AGCard 40 Pack 195-000 Box Contents:

The contents below are per a box (40 Tests):

Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip

Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent

Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test

Positive Control Swab (1) : Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab

Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained

Product Insert (1)

Procedure Card (1)

BinaxNow Product Documents

BINAXNOW COVID-19 AG CARD (PN 195-000) – INSTRUCTIONS FOR USE

Additional information

Weight N/A
Package Size

1 Kit (40 Tests), 1 Case(16 Kits/640 Tests), 1 Pallet (160 Kits / 6400 Tests)

Product Page - Get a Quick Quote

Instantly request a customized quote
Name(Required)

Have Questions?

Speak to a Mediu Representative Now!

Description

Product Details
Brand: BinaxNOW
MPN : 195-000
Manufacturer: Abbott Laboratories
Weight: 2 lbs

Description Of Our BinaxNOW™ 40 Pack COVID-19 Ag Card

For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only | MPN 195-000

Performance Data Submitted To The FDA By Abbott:

  • Sensitivity: 97.1%
  • Specificity: 98.5%

The BinaxNOW™ COVID-19 Ag Card 40 Pack Box (195-000) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Negative results should be treated as presumptive, 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.

The BinaxNOW™ COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW™ COVID-19 Ag Card is only for use under the Food and Drug Administration’s EUA.

Abbott BinaxNow AGCard 40 Pack 195-000 Box Contents:

The contents below are per a box (40 Tests):

Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip

Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent

Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test

Positive Control Swab (1) : Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab

Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained

Product Insert (1)

Procedure Card (1)

BinaxNow Product Documents

BINAXNOW COVID-19 AG CARD (PN 195-000) – INSTRUCTIONS FOR USE

Additional information

Weight N/A
Package Size

1 Kit (40 Tests), 1 Case(16 Kits/640 Tests), 1 Pallet (160 Kits / 6400 Tests)

Product Page - Get a Quick Quote

Instantly request a customized quote
Name(Required)

Have Questions?

Speak to a Mediu Representative Now!