COVID 19 Test Kits Archives - Mediu https://mediu.us/product-category/covid-19-test-kits/ Fri, 13 Jan 2023 21:35:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 212653171 Status Covid-19/Flu A/B https://mediu.us/product/status-covid-19-flu-a-b/ https://mediu.us/product/status-covid-19-flu-a-b/#respond Fri, 16 Dec 2022 19:41:34 +0000 https://mediu.us/?post_type=product&p=3455 Sample Type: nasopharyngeal swab specimens
Detection Method: Colloidal Gold
Detection Time: 15 minutes
COVID-19 – Anterior Nasal – Sensitivity 93.8%, Specificity 100%
Nasopharyngeal – Sensitivity 93.1%, Specificity 100%
• Flu A – Sensitivity 91.4%, Specificity 95.7%
• Flu B – Sensitivity 87.6%, Specificity 95.9%
Interim order: IO#326827
All necessary reagents provided and no equipment is needed

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]]> Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.

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 product 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.

 

Specifications:

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]]> https://mediu.us/product/status-covid-19-flu-a-b/feed/ 0 3455 ID NOW COVID-19 Control Swab Kit 2.0 https://mediu.us/product/id-now-covid-19-control-swab-kit-2-0/ https://mediu.us/product/id-now-covid-19-control-swab-kit-2-0/#respond Thu, 08 Dec 2022 03:43:24 +0000 https://mediu.us/?post_type=product&p=3438
  • ID NOW COVID-19 2.0 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms

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  • ID NOW COVID-19 2.0 Assay is for use under an Emergency use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
  • ID NOW COVID-19 2.0 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms
  • 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 high, moderate or waived complexity tests
  • The ID NOW COVID-19 2.0 assay 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
  • Kit contains: 12 Positive / 12 Negative Swabs
  • Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities
  • Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be confirmed with a different authorized or cleared molecular test in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and/or epidemiological information

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    ]]>     https://mediu.us/product/id-now-covid-19-control-swab-kit-2-0/feed/ 0 3438     ID NOW™ COVID-19 2.0 https://mediu.us/product/id-now-covid-19-2-0/ https://mediu.us/product/id-now-covid-19-2-0/#respond Tue, 06 Dec 2022 04:04:39 +0000 https://mediu.us/?post_type=product&p=3399 Kit Information: 24 tests / kit

    The ID NOWTM COVID-19 2.0 assay delivers molecular results in just minutes, giving you real-time access to the information you need to make actionable decisions during the first patient visit.

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    ]]>     POWERFUL CHOICES

    With ID NOW COVID-19 2.0, you now have the power to choose to test for COVID-19 only or COVID-19 plus influenza A&B with the same patient swab.

    UNCOMPROMISED PERFORMANCE

    The ID NOW COVID-19 2.0 assay is a nucleic acid amplification test (NAAT) that isothermally uses nicking enzyme amplification reaction (NEAR) technology. Thus, the ID NOW COVID-19 2.0 assay provides molecular results in a fraction of the time needed by traditional molecular lab tests.

    FAST DIAGNOSIS AND TREATMENT

    With positive results in as few as 6 minutes and negative results in 12 minutes or less, ID NOW COVID-19 2.0 provides real-time diagnostics where and when you need them — in near-patient settings at the point of care.

    SIMPLE AND SMART TECHNOLOGY

    The ID NOW platform is designed with intuitive operations that guide you at every step. The assay kit does not require refrigeration and contains all the components needed so you can test on-demand, right out of the box.

    Plus, the ID NOW platform easily integrates into existing patient diagnostic workflows and readily connects with hospital, laboratory, or patient information systems.

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    ]]>     https://mediu.us/product/id-now-covid-19-2-0/feed/ 0 3399     QuickVue At-Home COVID-19 Test (2 pack) https://mediu.us/product/quickvue-at-home-covid-19-test-2-pack/ https://mediu.us/product/quickvue-at-home-covid-19-test-2-pack/#respond Tue, 06 Dec 2022 03:04:47 +0000 https://mediu.us/?post_type=product&p=3392 The QuickVue At-Home OTC COVID-19 Test* offers rapid results in the privacy of your own home. Everything you need is included in the over-the-counter package, and taking the test is simple.

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  • Easy-to-use at-home COVID-19 testing kit provides results in just 10 minutes; non-invasive design makes it easy to gently swab your nose, place in pre-filled tube, and quickly get rapid test results; FDA Emergency Use Authorized and FSA/HSA eligible
  • Home COVID-19 test is quick, simple and designed for self-collected nasal swabs, ages 14 or older; Ages 2+ can be tested if adult collects sample; straightforward results with pink or blue line on test strip
  • At-home COVID-19 screening is for those with or without symptoms and takes approximately 10 minutes; this listing is for a single test kit. This test kit does not provide a document to present for certain uses, including air travel, re-entry requirements, or testing programs. Please check the requirements for your specific testing needs
  • Each kit includes: 2 individually-wrapped sterile foam swabs in order to test twice over 3 days with at least 24-36 hours between tests, pre-filled tubes (no measuring/counting drops), tube holder, instruction sheet, patient fact sheets
  • How To Use: 1. Swab – Collect a gentle nasal swab sample. 2. Swirl – After adding the swab to the solution tube. 3. Dip – Put the strip into the tube. 4. Read Results – Straightforward and easy-to-read results

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    Product Specifications

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    ]]>     https://mediu.us/product/quickvue-at-home-covid-19-test-2-pack/feed/ 0 3392     INDICAID® COVID-19 Rapid Antigen Test Kit (25 Pack) https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-25-pack/ https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-25-pack/#respond Tue, 06 Dec 2022 02:56:08 +0000 https://mediu.us/?post_type=product&p=3379 INDICAID Rapid Antigen Test is a fast, reliable, and affordable COVID-19 OTC Rapid Antigen Test that allows you to self-test anytime and anywhere to detect the presence of antigens found in or on the SARS‐CoV‐2 virus.

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    ]]>     USA SALES ONLY 

    A VALID CLIA NUMBER IS REQUIRED FOR PURCHASE.
    ENTER CLIA NUMBER IN THE SHOPPING CART AT THE TIME OF PURCHASE.

    • The INDICAID COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-coV-2 indirect anterior nasal swab specimens from individuals who are suspected of COVID-19.
    • For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures
    • Rapid results within 20 minutes
    • Detect SARS-CoV-2 nucleocapsid protein antigen
    • Effective in Detecting Omicron Variant (B.1.1.529) and specific variants of new coronavirus.*
    • Accuracy: Sensitivity 88.9%; Specificity 96.8%; Overall accuracy 95.6%

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    ]]>     https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-25-pack/feed/ 0 3379     INDICAID® COVID-19 Rapid Antigen Test Kit (12 Pack) https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-12-pack/ https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-12-pack/#respond Tue, 06 Dec 2022 02:44:31 +0000 https://mediu.us/?post_type=product&p=3372 COVID-19 RAPID ANTIGEN AT-HOME TEST is intended for the detection of SARS-CoV-2, the virus causing COVID-19 and can also detect Delta & Omicron. Over 45 Million INDICAID tests have been sold worldwide in 30+ countries EASY-TO-USE, QUICK & PAIN-FREE : No special training or equipment required. 4 easy steps to provide accurate result in 20

    Read More

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  • COVID-19 RAPID ANTIGEN AT-HOME TEST is intended for the detection of SARS-CoV-2, the virus causing COVID-19 and can also detect Delta & Omicron. Over 45 Million INDICAID tests have been sold worldwide in 30+ countries
  • EASY-TO-USE, QUICK & PAIN-FREE : No special training or equipment required. 4 easy steps to provide accurate result in 20 mins. Gently swab lower nasal cavity, insert swab in solution and stir, and pour 3 drops of solution onto testing device. Read clear and accurate results after 20 minutes.
  • ACCURATELY TESTS ASYMPTOMATIC OR SYMPTOMATIC OF AGED 2 OR ABOVE: Use by an individual 14+ years old, children aged 2-13 years should be tested by an adult. If you are asymptomatic and your test result is ‘negative’, suggest performing a 2nd test between 24 to 48 hours (after the initial test)
  • PERFECT FOR TRAVEL, SCHOOL, WORK & GATHERINGS: Self-test anytime and anywhere to detect the presence of the SARS‐CoV‐2 virus. Ideal for quick results when possible exposure has happened for peace of mind. Also, you can test at home or ‘on the go’ and obtain results in about 20 minutes
  • WHAT’S IN THE KIT: The INDICAID OTC COVID-19 Rapid Antigen At-Home Test (12-Tests) includes: 12 individually wrapped sterile nasal swabs, 12 single-use buffer solution vials, 12 individually packaged single-use test devices (Cartridges), 1 quick reference guide, 1 user instructions

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    Product Specifications

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    ]]>     https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-12-pack/feed/ 0 3372     INDICAID® COVID-19 Rapid Antigen Test Kit (2 Pack) https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-2-pack/ https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-2-pack/#respond Mon, 05 Dec 2022 20:34:16 +0000 https://mediu.us/?post_type=product&p=3360 INDICAID Rapid Antigen Test is a fast, reliable, and affordable COVID-19 OTC Rapid Antigen Test that allows you to self-test anytime and anywhere to detect the presence of antigens found in or on the SARS‐CoV‐2 virus.

    The post INDICAID® COVID-19 Rapid Antigen Test Kit (2 Pack) appeared first on Mediu.

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  • COVID-19 RAPID ANTIGEN AT-HOME TEST is intended for the detection of SARS-CoV-2, the virus causing COVID-19 and can also detect Delta & Omicron. Over 45 Million INDICAID tests have been sold worldwide in 30+ countries
  • EASY-TO-USE, QUICK & PAIN-FREE : No special training or equipment required. 4 easy steps to provide accurate result in 20 mins. Gently swab lower nasal cavity, insert swab in solution and stir, and pour 3 drops of solution onto testing device. Read clear and accurate results after 20 minutes.
  • ACCURATELY TESTS ASYMPTOMATIC OR SYMPTOMATIC OF AGED 2 OR ABOVE: Use by an individual 14+ years old, children aged 2-13 years should be tested by an adult. If you are asymptomatic and your test result is ‘negative’, suggest performing a 2nd test between 24 to 48 hours (after the initial test)
  • PERFECT FOR TRAVEL, SCHOOL, WORK & GATHERINGS: Self-test anytime and anywhere to detect the presence of the SARS‐CoV‐2 virus. Ideal for quick results when possible exposure has happened for peace of mind. Also, you can test at home or ‘on the go’ and obtain results in about 20 minutes
  • WHAT’S IN THE KIT: The INDICAID OTC COVID-19 Rapid Antigen At-Home Test (2-Tests) includes: 2 individually wrapped sterile nasal swabs, 2 single-use buffer solution vials, 2 individually packaged single-use test devices (Cartridges), 1 quick reference guide, 1 user instructions

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    Product Specifications

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    ]]>     https://mediu.us/product/indicaid-covid-19-rapid-antigen-test-kit-2-pack/feed/ 0 3360     BOSON Rapid SARS-CoV-2 Antigen Test Kit (2 Tests/Kit) https://mediu.us/product/boson-rapid-sars-cov-2-antigen-test-kit-2-tests-kit/ https://mediu.us/product/boson-rapid-sars-cov-2-antigen-test-kit-2-tests-kit/#respond Mon, 05 Dec 2022 20:09:11 +0000 https://mediu.us/?post_type=product&p=3348 Boson Rapid SARS-CoV-2 Antigen Test Card is authorized under the Emergency Use Authorization (EUA) to detect whether an individual is infected with COVID-19. Easy to use. No need to send your sample to the lab.

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  • FDA EUA Authorized COVID-19 Test Card: Boson Rapid SARS-CoV-2 Antigen Test Card is authorized under the Emergency Use Authorization (EUA) to detect whether an individual is infected with COVID-19. Easy to use. No need to send your sample to the lab.
  • 15 Min Rapid Test: 15-minute self-test. It can be performed anywhere at any time
  • Suitable for all events: Easy to carry with convenient size. Each kit contains 8 tests. It is suitable for all events.
  • Comfortable Self-test: The test can be used by yourself without the need for professional sample collection. Gently nasal swab collect the sample, comfortable at-home self test. Self-testing recommended for people aged 14 and above. Children aged 2 to 14 years should be tested by an adult.
  • Results Effective: It detects both symptomatic and non-symptomatic COVID-19 infection. It is the safe choice of at-home OTC product.

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    Product Specifications

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    ]]>     https://mediu.us/product/boson-rapid-sars-cov-2-antigen-test-kit-2-tests-kit/feed/ 0 3348     InteliSwab, at-Home COVID-19 Rapid Antigen Test (2 Tests/Kit) https://mediu.us/product/inteliswab-at-home-covid-19-rapid-antigen-test-2-tests-kit/ https://mediu.us/product/inteliswab-at-home-covid-19-rapid-antigen-test-2-tests-kit/#respond Mon, 05 Dec 2022 19:45:42 +0000 https://mediu.us/?post_type=product&p=3339 Meet InteliSwab, the COVID-19 rapid antigen test that makes self-testing remarkably simple. It's so user-friendly, it can be used anytime and anywhere, and requires less than one minute of hands-on time.

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  • 1. REMARKABLY SIMPLE: InteliSwab’s unique all-in-one swab and test device means no drops to measure and no difficult or confusing steps. Simply Swab, Swirl, and See your results in minutes (for complete testing instructions, see the User Manual). 98% of untrained users found InteliSwab easy to use.
  • 2. HIGHLY ACCURATE: InteliSwab detects active COVID-19 infection for both symptomatic and asymptomatic use. InteliSwab detects COVID-19 variants including Delta & Omicron BA.2, BA.2.12.1, BA.3 and BA.5 subvariants. InteliSwab has 93% accuracy.
  • 3. TESTING FOR YOUR FAMILY: InteliSwab is suitable for ages 2 and up. Get peace of mind in your test results when gathering with family and friends.
  • 4. FDA AUTHORIZED FOR HOME USE: InteliSwab requires less than one minute of hands-on time. This test can be completed anywhere, anytime without the need to ship your sample to a lab or to get a prescription from your healthcare provider.
  • 5. EXPERIENCED MANUFACTURER: DESIGNED AND DEVELOPED IN THE USA. In business for over 30 years.

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    Product Specifications
    Brand Name Orasure
    Color Purple
    Ean 0608337001570 , 0608337001624
    Global Trade Identification Number 00608337001624
    Model Number 1001-0622
    Part Number 1001-0622
    Temperature Rating Storage: 2 to 30 Celsius
    UNSPSC Code 42000000
    UPC 608337001624 , 608337001570

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    ]]>     https://mediu.us/product/inteliswab-at-home-covid-19-rapid-antigen-test-2-tests-kit/feed/ 0 3339     On/Go OTC https://mediu.us/product/on-go-otc/ https://mediu.us/product/on-go-otc/#respond Wed, 30 Nov 2022 23:39:17 +0000 https://mediu.us/?post_type=product&p=3318 On/Go(TM) is the FDA-authorized, fast and easy-to-use COVID-19 self-test and companion app that guides you step-by-step through the testing process. In only 10 minutes, you will have the results you need to confidently return to work, school, sports and all the things you love to do, with the ability to store and share your family's and your test results from the intuitive On/Go app.

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    On/Go(TM) is the FDA-authorized, fast and easy-to-use COVID-19 self-test and companion app that guides you step-by-step through the testing process. In only 10 minutes, you will have the results you need to confidently return to work, school, sports and all the things you love to do, with the ability to store and share your family’s and your test results from the intuitive On/Go app. The test is paired with a free, intuitive mobile-app, available on the Apple and Google app stores, that provides step-by-step instructions and results management. With On/Go, feel confident in your COVID-19 status, quickly, without having to ship samples to a lab and without the need for a prescription from your healthcare provider. Simply “tap, swab, and snap” your way to COVID-19 results.

    Features

    • Quick and Easy to Use: The On/Go COVID-19 Antigen Self-Test by Intrivo uses a shallow nasal swab for maximum comfort, with collection you can perform for yourself or another at home or any place where you can find a flat surface.
    • Quality You Can Trust: In just 10 minutes, On/Go delivers results with 95% accuracy and is effective at detecting all known variants of concern.
    • Step-by-Step Instructions: The On/Go companion app, downloadable by scanning the QR code on box or available in the Apple App Store and Google Play, guides you seamlessly through each test step, from specimen collection to results interpretation.
    • Shareable Test History: With the On/Go app, you can easily view, track and share test results with family and friends, all in one place.
    • User Friendly For All Ages: The On/Go Self-Test is indicated for children as young as 2 years old when administered by an adult, and for all people 14 and older to self-perform.
    • Proudly Made in the USA: Manufactured in the United States with 30 years’ experience and full quality controls.

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