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CLIA Waived 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. The CLIA Waived COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only. Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. About Test Device EUA Authorized CE Mark Test does NOT give positive or negative result for COVID-19 virus. This is an antibody test, it only indicates past or recent infection. Read Results in 15 Minutes 9 Month Expiration from Date of Manufacture Contents 20 Test Devices 20 Disposable Pipettes 20 Alcohol Prep Pads Sterile Safety Lancets Buffer Package Insert
The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between 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., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Lateral flow assay Detect SARS-CoV-2 nucleocapsid protein antigen Rapid results within 10-15 minutes Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use only For prescription use only For use with direct anterior nasal and nasopharyngeal swab specimens Clinical Performance 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab 87.18% PPAa and 100% NPAb when used with anterior nasal swab
Master Carton - Contains 625 Tests For International Sale Only - Call for Pricing The COVID-19 IgG/IgM Rapid Test Device is an in vitro Immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only. Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. About Test Device Gives Positive or Negative Result for COVID-19 IgM/IgG antibodies Read Results in 15 Minutes Contents of each box 25 Test Devices 25 Disposable Pipettes 25 Alcohol Prep Pads Sterile Safety Lancets Buffer Package Insert
7 packs retail for $0.99 Container information 1 Carton 2450 pcs 7 pcs x (350 pk) 1 container 760 Cartons (760 x 2450) = 1,862,000 pcs
Certification - Test report-Certified Daily manufacturer output - 200,000 Price - $15.00 per test
- RT-PCR Test Kit Manufactured from South Korea - FDA EUA - CE - ISO - 1 Kit = 100 Tests - MOQ = 30,000 Tests or 300 Kits - Price is $11.00 per test or $1,100 per test kit
Test kits for covid-19 We have testing kits for Covid-19 In inventory now for immediate shipping. High sensitivity rapid test kits for Covid-19. 250K available now for USA and international shipping, Inventory moving fast.
Covi-G (powered by Cipla) Rapid Test kit combines quality, efficacy and convenience - offering precise results in 10-15 mins Features & Benefits Covid IgM-IgG Serologic Rapid Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies against SARS-CoV-2 in whole blood in vitro Precise and effective - Tests for both IgM and IgG antibodies - Sensitivity and specificity comparable to highest available offerings Sensitivity: IgG 92%, IgM 82%; Specificity IgG 97%, IgM 94% - ->92% total accuracy: IgG 96,5% - IgM: 92,8% - High reproducibility (consistent results across the same patient) - High quality, reliable & convenient - Single-prick blood test - 10-15 minutes per test - Intuitive visual interpretation - No specialized training or equipment needed - Portable hence highly scalable - Storage at room temperature (2-30 C) - Conformance to CE (Europe) and ISO manufacturing The Covi-G platform for Rapid Antibody tests has a set of unique and unparalleled offerings SUSTAINABLE QUALITY Validated Declaration of CE conformity - Launched in Feb 2020, among the earliest technologies/ kits to declare CE-compliance, and continuing strong compared to competitors - Under process for receiving USDA E authorization Among only 3 integrated vendors of Rapid tests Developed and manufactured in Europe (Belgium) - One of the very lew players manufacturing in Europe, with zero complaints also certified locations ACCEPTABILITY ACROSS MARKETS Demonstrated capabilities in local countries validation - Independent local studies conducted in Belgium and France, validating the sensitivity and specificity of the product Participated in published research - Covl-G kit compared lavorably with 7 lgFL IgM rapid antibody tests and IgG ELISA in a comparative study published by Elsevier Science Direct, verifying sensitivity of the kit PROVEN COMMERCIAL EXPERIENCE Sold in 25+ countries already - Including Europe, US, Canada, Africa and multiple developed and emerging markets - Under participation in govt tenders Robust manufacturing capability and capacity - ISO-certified manufacturing site - Ability to cater to high manufacturing volumes from Belgium, to ensure adequale QA and commercial viability AFFORDABLE AND SCALABLE Viable to scale up at Institutions and Retail level - Economical cost per-unit established over many months of process improvement and local manufacturing - Can cater to insured as well as out-of pocket populations Continuous improvement through R&D - Multiple rounds of performance testing complete, further testing in 5 reputed hospitals underway in Belgium, France, USA and Canada - Other platforms including Rapid antigen testing also being developed The price is per unit, the minimum is 25000 units
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