1. Generic Name: Novel Coronavirus COVID-19 IgG Antigen Test Kit 2. Brand Name: NIL 3. Notified Category: Other than above substances intended for qualitative determination of COVID-19 infection 4. Class of Medical Device: Class D 5. Shelf life :15 months 6. Sterile/Non-Sterile: Non-Sterilized 7. Contains Drugs: No 8. Medical Device Grouping Category: IVD-Kit 9. Grouping Description: Intended for qualitative determination of COVID-19 infection 10. Intended Use: The Novel Coronavirus COVID-19 IgG Kit is intended for the qualitative detection of human anti-COVID- 19 IgG antibody in human serum/plasma. Any reactive specimen with the Novel Coronavirus COVID-19 IgG Kit must be confirmed with alternative testing method(s). 11. Product Description: Assay controls and 1:10 diluted human serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length recombinant protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of "COVID-19 recombinant antigen-human anti-COVID-19 IgG antibody - HRP labeled anti human IgG tracer antibody" is formed if there is specific Coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP-Labeled tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen. SALIENT FEATURES: â?¢ Recombinant COVID-19 Spike subunit Protein coated on Microwell Plate â?¢ HRP Conjugated Polyvalent Anti-Human IgG â?¢ Assay Time: 80 mins (30mins+30 Mins+20mins) â?¢ Strip Format Microwell Plate â?¢ Ready to use Substrate and Controls â?¢ Only 20 pL of human serum is required for measurement in duplicate. â?¢ Works on any open ELISA system â?¢ Assay procedure is easy to automate OUR TEST: â?¢ Principle: Indirect ELISA â?¢ The normal healthy patients with samples collected prior to the COVID-19 outbreak [December 3, 2019] (n = 150) and RT-PCR confirmed positive patients in after the second week of the onset of the disease (n = 32). The Positive sample evaluation was done at external Approved Lab. The results are as follows: â?¢ Diagnostic sensitivity is 100% (>98%) â?¢ Diagnostic specificity is 98.67% (>97%) â?¢ PPV: 94.12�°/0 â?¢ NPV: 100% Please contact us for more information and product details.
- Can see the results in a short time 30 min. - More convenient than using blood. - Rapid production and supply are possible. - Convenient for personal use or at home. - Sensitivity 95% - Certified For EUROP And USA - Min order Discussed, Quote First - Fast delivery all Around the world By DHL FEDEX - In stock Korea by OTG. * Can supply Blood type Rapid test kit avail
INVBIO Covid Antigen Ag saliva rapid test card Sensitivity: 97.1% Specificity: 99% Agreement: 99.57% 10 miuntes to get the result. MOQ for each: 500 tests, 25 tests/box,
Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in oropharyngeal swabs and bronchoalveolar lavage fluid collected from individuals suspected of COVID-19 by their healthcare provider. A kit contains: Package specifications: 24 tests/kit, 48 tests/kit 1) 2019-nCoV-PCR Master Mix (Lyophilized Powder): 1 bottle/box 2) 2019-nCoV-PCR Positive Control (Lyophilized Powder):1 bottle/box 3) 2019-nCoV Diluent: 1 bottle/box 4) User Manual
Intended Use Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in oropharyngeal swabs and bronchoalveolar lavage fluid collected form individuals suspected of COVID-19 by their healthcare provider. About SARS-CoV-2 Specific antibodies will be produced within days to weeks as the immune system makes immune defense against the SARS-CoV-2 infection. Total antibody detection is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical symptoms and result of other diagnostic methods. The test result should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection. Total antibody may not be detected in the first few days of infection. SARS-CoV-2 neutralizing antibody is a protective soluble protein secreted by adaptive immunizing cells after inoculation with SARS-CoV-2 vaccine or infection with SARS-CoV-2. These antibodies can specific bind with virus RNA binding domain (RBD) to block the binding of RBD with angiotensin-converting enzyme 2 (ACE2) on human cells surface, thus prevent the virus or its genetic material into the human cell and virus infection. Benifits of the Kit 1) Room Temperature Transportation 2) Cost-Effective Shipping The shipping is at room temperature, with no need of cold chain shipping. 3) Highly Sensitive, Highly Specific Highly sensitive and highly specific for 2019-nCoV, reliable identification of COVID-19. 4) Environmentally Friendly The kit needs neither bulky packaging nor cold chain shipping. Contents A kit contains: Package specifications: 24 tests/kit, 48 tests/kit 1) 2019-nCoV-PCR Master Mix (Lyophilized Powder): 1 bottle/box 2) 2019-nCoV-PCR Positive Control (Lyophilized Powder):1 bottle/box 3) 2019-nCoV Diluent: 1 bottle/box 4) User Manual Note: Do not mix or interchange different batches of kits.
Great for Kids. From as little as $1.00 FoB per test - including IFU in Language of your choice! COVID Rapid Test / Lateral Flow - SARS-CoV-2 Antigen Kit Self Test Kit - Saliva based - Lollipop Style - Qualitative - IVD (Invitro diagnostic medical device) - Rapid immunochromatographic assay - 15 Minutes test to result - Shelf Life 18 months - EU common list approved. - In use: BE, BG, CY, FR, RO, SI, ES - Validation Completed: - FR, DE, ES UK DHSC Approved. - Validation completed & In use - Specificity 100.0% - Sensitivity 93.0% Certifications: EU HSC Approved UK DHSC Approved (included in JRC database) CE Directive 98/79/EC EN ISO 13485:2016 BS EN 13612:2002 ISO 14971:2019 EN ISO 23640:2015 ISO 15223-1:2016 EN ISO 18113-1:2011 EN ISO 18113-4:2011 EN 62366-1:2015 More Information is available at our website. Please contact us directly, visit our website, follow us on LinkedIn and/or Instagram. @fiigureofficial in = fiigureofficial
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains: GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request. To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away. 1. Nasopharyngeal 2. Nasal 3. Saliva Price and Minumum Quantity Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet Sample: Available. Sample Cost Born By Supplier Product Model And Origin Brand: GENEDIAModel: 643G-S (Saliva) Seller Code: Genedia w covid 19 agHS Code: 3002.15 Standards: Ce Competitive Advantages Allow wider testing with fast test time (10 minutes) All necessary materials provided / no equipment needed Sensitivity: 93.33%, specificity: 100% Free sample. no moq. price is negotiable. customized packing. Other Details 20 tests / kit 24 months from the date of manufacture 2 ~ 30c(35.6 ~ 86f) available for room temperature deliver In stock. fast delivery. 1 x Instructions for Use Manual 40 x Test Cassettes 1 x Buffer 40 x Dropper