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Assure Tech Point of Care Fingerstick Antibody Test for COVID-19 (25/box)

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Assure Tech Point of Care Fingerstick Antibody Test for COVID-19 (25/box)

Item #:

  • $525.00

⚕️ For Hospitals, Laboratory & Certified Medical Professional Use Only ⚕️
** To order call 888-562-5852. Bulk rates available. **

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FDA Authorized Point-of-Care Antibody Test for COVID-19

    • 25 tests per box
    • FDA Emergency Use Authorization (EUA)
    • Authorized for use in CLIA-Waived POINT-OF-CARE settings
    • Reimbursement Code 86328
    • 24 month shelf life from date of manufacture
    • Easy to use, results in minutes

 
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

This test is also authorized for use with fingerstick whole blood specimens only 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. 



** Call to place order at 888-562-5852 **

 

FACT SHEET (TEST RECIPIENTS)
FACT SHEET (HEALTHCARE PROVIDERS)
IFU (INSTRUCTIONS FOR USE (PACKAGE INSERT)
FDA EMERGENCY USE AUTHORIZATION (EUA) LIST


COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This test provides only a preliminary test result and is for professional use only.

This is a blood test that will screen for antibodies to help determine if you have been exposed to the virus. This test is highly sensitive and specific.


TEST PROCEDURE



MATERIALS SUPPLIED

25 sealed pouches each containing test cassette and dropper
25 lancets
25 alcohol prep pads
1 bottle of buffer solution
1 package insert


** Call to place order at 888-562-5852 **



  • This test has been authorized by FDA under an EUA for use by authorized laboratories
  • This test has not been FDA cleared or approved
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

FREE Shipping on all orders over $50!

Items will ship UPS Ground or equivalent unless other arrangements are made. Most orders will ship same day. We always make it a priority to get your order shipped as soon as possible.

** For expedited shipping please call 888-562-5852 to make arrangements. **

Order confirmation

Upon placing order you will receive an email order confirmation. This means that we have received the order and pre-authorized your credit card for the purchase. We will then make sure that the item(s) are immediately available to ship (within 3 business days – most items ship same or next day). Upon verifying this we will process the charge and fulfill the order for shipment. If the item you ordered is not available for immediate shipment we will notify you via email and/or phone to see how you would like to handle the order. If the item ordered is not available or on backorder we will void the pre-authorization and notify you via email.

Tracking Information

When the order ships you will be sent an email with the tracking number. Enter this information on the Track Your Order page to get the latest in-transit updates. Most items will get delivered within 1-4 business days.

Damages

Inspect all packages upon delivery. Should there be any damage to the package make note of it when signing for package receipt. If your item(s) do arrive damaged please take a photo and send it to returns@toxtests.com. We will process an insurance claim on your behalf.

Cancellations & Refunds

All orders cancelled after 48 hours are subject to a $20 administration fee regardless of whether or not your item(s) has shipped. If the order has already shipped, you (the buyer) will be responsible for all return shipping charges plus a 25% restocking fee. Refunds will only be issued to the credit card used for the initial purchase. Tests kits are packaged 25 per box and we do not accept returns for less than complete boxes. No refund requests are accepted after 30 days of purchase.

Returns are accepted only within 30 days of the purchase date. All returned items must be unopened. No returns will be accepted without prior approval and a Return Merchandise Approval (RMA) number. Contact us for the RMA number and the appropriate return address.


                    

We guarantee you the best price online — to prove this, we will give you 30 days to find a better deal elsewhere. If you find one we will refund you the difference. We want you to be sure that you are getting the best deal on the items you order.

To request a partial refund simply email refund@toxtests.com and include a link to the item advertised online.

Limitations:

  • You must purchase item from our website before requesting partial refund.
  • Refunds can only be credited back to the credit card used for initial payment.
  • Special promotions such as rebates or buy one, get one free offers are not eligible.
  • The item must be in stock on competitors website.
  • Discounter or auction website are excluded (Ebay, etc.).
  • The price match guarantee applies only to item price and shipping charges. It excludes sales tax.

Listed below are the most common drug abbreviations, detection times, and cutoff levels used for point-of-care rapid drug and alcohol screening products. Please note that although most of the abbreviations are universal there are a few that differ slightly depending on the manufacturer of the test device (e.g. mAMP = MET; MOP = OPI300). Please contact us if you need clarification on anything.


Drug Test Strip Abbreviations, Drug Test Detection Times and Cut-off Levels

FDA Authorized Point-of-Care Antibody Test for COVID-19

    • 25 tests per box
    • FDA Emergency Use Authorization (EUA)
    • Authorized for use in CLIA-Waived POINT-OF-CARE settings
    • Reimbursement Code 86328
    • 24 month shelf life from date of manufacture
    • Easy to use, results in minutes

 
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

This test is also authorized for use with fingerstick whole blood specimens only 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. 



** Call to place order at 888-562-5852 **

 

FACT SHEET (TEST RECIPIENTS)
FACT SHEET (HEALTHCARE PROVIDERS)
IFU (INSTRUCTIONS FOR USE (PACKAGE INSERT)
FDA EMERGENCY USE AUTHORIZATION (EUA) LIST


COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This test provides only a preliminary test result and is for professional use only.

This is a blood test that will screen for antibodies to help determine if you have been exposed to the virus. This test is highly sensitive and specific.


TEST PROCEDURE



MATERIALS SUPPLIED

25 sealed pouches each containing test cassette and dropper
25 lancets
25 alcohol prep pads
1 bottle of buffer solution
1 package insert


** Call to place order at 888-562-5852 **



  • This test has been authorized by FDA under an EUA for use by authorized laboratories
  • This test has not been FDA cleared or approved
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

FREE Shipping on all orders over $50!

Items will ship UPS Ground or equivalent unless other arrangements are made. Most orders will ship same day. We always make it a priority to get your order shipped as soon as possible.

** For expedited shipping please call 888-562-5852 to make arrangements. **

Order confirmation

Upon placing order you will receive an email order confirmation. This means that we have received the order and pre-authorized your credit card for the purchase. We will then make sure that the item(s) are immediately available to ship (within 3 business days – most items ship same or next day). Upon verifying this we will process the charge and fulfill the order for shipment. If the item you ordered is not available for immediate shipment we will notify you via email and/or phone to see how you would like to handle the order. If the item ordered is not available or on backorder we will void the pre-authorization and notify you via email.

Tracking Information

When the order ships you will be sent an email with the tracking number. Enter this information on the Track Your Order page to get the latest in-transit updates. Most items will get delivered within 1-4 business days.

Damages

Inspect all packages upon delivery. Should there be any damage to the package make note of it when signing for package receipt. If your item(s) do arrive damaged please take a photo and send it to returns@toxtests.com. We will process an insurance claim on your behalf.

Cancellations & Refunds

All orders cancelled after 48 hours are subject to a $20 administration fee regardless of whether or not your item(s) has shipped. If the order has already shipped, you (the buyer) will be responsible for all return shipping charges plus a 25% restocking fee. Refunds will only be issued to the credit card used for the initial purchase. Tests kits are packaged 25 per box and we do not accept returns for less than complete boxes. No refund requests are accepted after 30 days of purchase.

Returns are accepted only within 30 days of the purchase date. All returned items must be unopened. No returns will be accepted without prior approval and a Return Merchandise Approval (RMA) number. Contact us for the RMA number and the appropriate return address.


                    

We guarantee you the best price online — to prove this, we will give you 30 days to find a better deal elsewhere. If you find one we will refund you the difference. We want you to be sure that you are getting the best deal on the items you order.

To request a partial refund simply email refund@toxtests.com and include a link to the item advertised online.

Limitations:

  • You must purchase item from our website before requesting partial refund.
  • Refunds can only be credited back to the credit card used for initial payment.
  • Special promotions such as rebates or buy one, get one free offers are not eligible.
  • The item must be in stock on competitors website.
  • Discounter or auction website are excluded (Ebay, etc.).
  • The price match guarantee applies only to item price and shipping charges. It excludes sales tax.

Listed below are the most common drug abbreviations, detection times, and cutoff levels used for point-of-care rapid drug and alcohol screening products. Please note that although most of the abbreviations are universal there are a few that differ slightly depending on the manufacturer of the test device (e.g. mAMP = MET; MOP = OPI300). Please contact us if you need clarification on anything.


Drug Test Strip Abbreviations, Drug Test Detection Times and Cut-off Levels

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