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Sure Status® COVID-19 Antigen Card Test
USD $43.75
Quantity:
Description

Sure Status® COVID-19 Antigen Card Test is a lateral flow immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider.

WEIGHT (KG): 0.33
Description:
<p><span style="color:#7c96a3">Sure Status&reg; COVID-19 Antigen Card Test is a lateral flow immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider.</span></p>
Product Bundled: []
Intended use: Sure Status® COVID-19 Antigen Card Test is a lateral flow immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider. Sure Status® COVID-19 Antigen Card Test is for in vitro diagnostic use and intended as an aid to the detection of nucleocapsid protein antigen in a patient with clinical symptoms of SARS-CoV-2 infection. It provides only initial screening test results and a more specific alternative diagnosis method should be performed to obtain the confirmation of SARS-CoV-2 infections. The test is not automated and does not require any additional instrument. The test is designed to be performed by laboratory professionals/trained users only. The product can be used in a clinical setup and point-of-care sites that meets the requirements stated in the Instructions for Use or local regulations.
Intended user: The product can be used in a clinical setup and point-of-care sites that meets the requirements stated in the Instructions for Use (IFU) or local regulations.
Technology principle: Immunochromatography
Antigen target: SARS-CoV-2 Nucleocapsid Antigen
Test format: Lateral flow assay (strip or cassette)
Sample type: Nasopharyngeal swab
Sensitivity: 94.16%
Specificity : 100%
Number of tests per unit: 25 tests per box
Shelf life : 24 months
Packaging and labelling: 25 tests per box
Storage conditions: 4-30°C
Operating conditions: 15-30°C
HS code: 30021500
Cold chain requirements: No
Contents of kit: 25 individually packaged tests, swabs, buffer vials, Instructions for Use
Equipment required but not provided: None
Instrument requirements: None
Name of manufacturer : Premier Medical Corporation Private Limited
Country of manufacture: India
Ordering and Incoterms:
<ul> <li><span style="color:#7c96a3">Prices are indicative and reflect&nbsp;the ex-works price available for 1 pack of 25 tests for order volumes over 80,000 test kits (see Volume Pricing below)</span></li> <li><span style="color:#7c96a3">Ex-works prices are exclusive of taxes and shipping.&nbsp;Incoterms are negotiated between the supplier (or its local distributor) and the buyer</span></li> <li><span style="color:#7c96a3">The final price is dependent on: Incoterms, order volume, freight, taxes, customs duties, handling fees and other applicable fees</span></li> <li><span style="color:#7c96a3">Upon Request for Quotation, the buyer will receive a quotation with the applicable final price. Learn more about pricing on the DxConnect Marketplace in our helpdesk </span><u><a href="https://diagnostics.zendesk.com/hc/en-us/articles/4429547242521-Pricing-on-DxConnect-Marketplace" target="_blank"><span style="color:#7c96a3">here</span></a></u><span style="color:#7c96a3">.</span></li> </ul>
Volume pricing:
<p><span style="color:#7c96a3">Prices are indicative ex-works prices for 1 box of 25 tests in US Dollars. Tiered pricing is available for the following order volumes:</span></p> <table border="1" bordercolor="#ccc" cellpadding="5" cellspacing="0" style="border-collapse:collapse"> <tbody> <tr> <td style="height:63.45pt; text-align:center; vertical-align:middle; white-space:normal; width:132pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><strong><span style="font-family:Calibri,sans-serif">Volume of tests ordered</span></strong></span></span></p> </td> <td style="height:63.45pt; text-align:center; vertical-align:middle; white-space:normal; width:144pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><strong><span style="font-family:Calibri,sans-serif">Volume of test kits ordered (1 kit contains 25 tests)</span></strong></span></span></p> </td> <td style="height:63.45pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><strong><span style="font-family:Calibri,sans-serif">Indicative price per test (USD)</span></strong></span></span></p> </td> <td style="height:63.45pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><strong><span style="font-family:Calibri,sans-serif">Indicative price per test kit (USD)</span></strong></span></span></p> </td> </tr> <tr> <td style="height:31.75pt; vertical-align:middle; white-space:normal; width:132pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">10,000 - 499,999 tests</span></span></span></p> </td> <td style="height:31.75pt; vertical-align:middle; white-space:normal; width:144pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">400 - 24,999 test kits</span></span></span></p> </td> <td style="height:31.75pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">2.5</span></span></span></p> </td> <td style="height:31.75pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">62.5</span></span></span></p> </td> </tr> <tr> <td style="height:31.75pt; vertical-align:middle; white-space:normal; width:132pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">500,000 - 1,999,999 tests</span></span></span></p> </td> <td style="height:31.75pt; vertical-align:middle; white-space:normal; width:144pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">25,000 - 79,999 test kits</span></span></span></p> </td> <td style="height:31.75pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">2</span></span></span></p> </td> <td style="height:31.75pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">50</span></span></span></p> </td> </tr> <tr> <td style="height:15.9pt; vertical-align:middle; white-space:normal; width:132pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">&gt;2 million tests</span></span></span></p> </td> <td style="height:15.9pt; vertical-align:middle; white-space:normal; width:144pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">&gt;80,000 test kits</span></span></span></p> </td> <td style="height:15.9pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">1.75</span></span></span></p> </td> <td style="height:15.9pt; text-align:center; vertical-align:middle; white-space:normal; width:75pt"> <p><span style="color:#7f8c8d"><span style="font-size:14px"><span style="font-family:Calibri,sans-serif">43.75</span></span></span></p> </td> </tr> </tbody> </table> <p>&nbsp;</p>
Pricing Description: Ex-works price for 1 pack of 25 tests for orders over 80,000 test kits
Custom search fields: COVID-19 Antigen RDT
Stringent Regulatory Approval: WHO EUL
National Regulatory Approval: Botswana BoMRA, Brazil ANVISA, Ethiopia FMHACA, Ghana FDA, India CDSCO, Jamaica MoHW, Kenya Pharmacy and Poison Board, Laos FDA, Nigeria NAFDAC, North Macedonia AMPMD, Philippines FDA, Sri Lanka NMRA, Thailand FDA, Uruguay MSP
Country Availability: Albania, Bangladesh, Botswana, Brazil, Congo, Dem. Rep., El Salvador, Ethiopia, Georgia, Ghana, India, Jamaica, Kenya, Lao PDR, Mali, Myanmar, Nigeria, North Macedonia, Philippines, South Africa, Thailand, Uruguay
Reporting units : IFCC (mmol/mol) / NGSP/DCCT (%)


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