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BinaxNOW 40 Pack COVID-19 AgCARD By Abbott 195-000

$299.00$4,784.00

BinaxNow Ag Card POC 40 Pack 195-000

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BinaxNOW 40 Pack COVID-19 AgCARD Poc (195-000)

BinaxNow 40 Pack 195-000 Expiration Extension Letter For BinaxNow COVID19 AgCard

For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only | MPN 195-000 | CPT Code: 87811

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. The 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 195-000 AGCard 40 Pack Box Contents:?

  • 40 cardboard, book-shaped test cards with test strips
  • 1 bottle of extraction reagent (7.5 mL)
  • 40 sterile nasal swabs
  • 1 positive control swab
  • Non-infectious SARS-CoV-2 nucleocapsid antigen
  • 1 negative control swab
  • 1 instruction manual
  • 1 procedure guide

Instructions For The BinaxNOW COVID-19 Ag Card CLIA Waived 40/Bx

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.
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.

Performance Data Submitted To The FDA By Abbott for the BinaxNOW 40 Pack COVID-19 AgCARD 195-000:

  • Sensitivity: 97.1%
  • Specificity: 98.5%

Buy the BinaxNow AG Card POC by Abbott Box Today

Peach Medical offers BinaxNow 40 pack antigen POC tests in bulk, so you’ll have an ample supply for those who need them. Purchasing the BinaxNow AG CARD 195-000 antigen tests in bulk helps you to be prepared for whenever you or someone in your surroundings requires a COVID-19 antigen test. Please call us at 1-877-597-3224 or e-mail us at [email protected] for wholesale pricing. We are happy to provide references in theatre, government, banking, education, fortune 500 companies, and 50,000+ orders of test kits sold over the past year.

Product Documents

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

DISCLAIMER

  • For in vitro diagnostic use.
  • In the USA, the BinaxNow 40 Pack Ag Card has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Additional information

Weight 2 oz
Dimensions 10 × 10 × 6 in
Brand

BinaxNow

MPN

195-000

Manufacturer

Abbott

Package Size

40 Tests, 640 Tests

How Long Does It Take For My Item(s) To Ship?

Items are shipped Monday - Friday from our warehouse. 1-2 Day Processing Time.

Delivery times vary according to your selected delivery address, the availability of your items, and the time of day you place your order.

For B2B accounts, please get in touch with us at [email protected] for urgent order requests.

Please feel free to visit our Support Page for FDA Extension Letters, Submit a Ticket, and more.

What Shipping Methods Do You Offer?

At Peach Medical Corp we use UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. Currently, our shipping methods are as follows:

  • UPS Next Day Air 

  • UPS 2nd Day Air

  • UPS Ground (3-5 Day Delivery)

When Will I Receive My Tracking Number?

Our system updates clients every evening with tracking numbers for their orders. This will be sent via e-mail with an additional copy of your receipt.

Incorrect Address

Please verify your address when ordering, we are unable to fix an incorrect shipping address on an order once it is in transit. If your order is in transit with an incorrect address, please reach out to your carrier to reroute the package. Peach Medical Corp. is not able to have packages rerouted or contact the carrier for you.

Refunds will not be issued for packages that were shipped to an incorrect address but it may be possible for a replacement package to be sent, please contact the customer service team to see if you are eligible.

Return Policy and Cancellation Policy

The Peach Medical COVID-19 Antigen Rapid Test and all face masks are Non-returnable & Non-refundable as they are considered personal-use items. Replacement may be shipped if the item is defective. Proof of purchase, photos of defects, lot numbers, and other information are required to authorize a replacement. Please reach out to customer service for detailed requirements before disposing of the defective units. We will not replace your COVID-19 Antigen Rapid Test kits that are expiring soon based on the printed label. Our expiration dates have been shown on each product page. More information can be found at support.peachmedical.com/portal/en/kb/peachmedicalsourcing. We will continue to update the FDA documents for shelf-life extensions for our tests.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical is not responsible for any goods once they leave our warehouse and when tracking is provided. I.e Gifts, International Shipping Services. All Products must be packed in the original, unopened, and unmarked packaging including any accessories, manuals, documentation, and registration that shipped with the Product.

Note: If Peach Medical has not shipped your item within 7 business days, cancellations will be honored. Please email us at [email protected] for return authorization and the shipping address.

BinaxNow 40 Pack POC Ag Card Frequently Asked Questions

How Long Does It Take For The BinaxNow POC to Give Results?

The BinaxNow Ag Card provides results within 15 minutes.

What Does The BinaxNow Ag Card Detect?

The BinaxNOW COVID-19 Ag Card does not differentiate between SARS-CoV and SARS-CoV-2.

Who Can Use The Respiratory Test Kit BinaxNOW™ Professional Use COVID-19 Ag 40 Tests?

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.

What Is The CPT Code For BinaxNow 40 POC Ag Card?

CPT Code: 87811

How Reliable Is The BinaxNow COVID-19 Ag Card?

The sensitivity of the BinaxNOW™ COVID-19 Test Ag Card was 67.6% (95% CI: 50.2–81.9%), and the specificity was 100.0% (95% CI: 97.9–100.0%).

When Does The BinaxNow Card Expire?

Expiration Date Extension: Testing has been completed to support a shelf-life (expiration date) of up to 22 months.

36 reviews for BinaxNOW 40 Pack COVID-19 AgCARD By Abbott 195-000

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    BinaxNOW 40 Pack COVID-19 AgCARD By Abbott 195-000

    Quick Order Process

    Easy to order at a great price! Product arrived earlier than expected!

    January 10, 2023

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    Paul

    Quick Order Process

    Easy to order at a great price! Product arrived earlier than expected!

    January 10, 2023

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    BinaxNOW 40 Pack COVID-19 AgCARD By Abbott 195-000

    Shipping Fast

    very fast shipping and delivery, items as ordered, good price.

    December 19, 2022

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