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.
US FDA approved test kit 93.3% sensitivity in confirming COVID-19 cases. Nasopharyngeal test We have OTG and production deals
We, CentZone, are proudly offer you COVID-19 Self-Test Kit as below. Required document must be submitted in order to provide detail information of each Test Kits. Otherwise no information will be available. If you are willing to order and purchase below COVID-19 Self-Test Kits, please do send below information in LOI contract by return at oversea@centzone.co.kr [Required Documents] * LOI Contract - LOI contract must include below information as a mandatory - Local sales company information including Tel, Address, E-mail, Website, Business Registration Number and name of the person in charge. - Company Profile for both broker and end-sales company. - Yearly Forecast Volume [COVID-19 SELF-TEST KIT PRODUCT] 1. Genbody COVID-19 Self-Check Kit *FDA Certificates. (1) Professional Use : MOQ 100,000 Kits $5.00/Kit --> 25 Kits per Set (2) Home Use : MOQ 100,000 Kits $6.00/Kit --> 2 Kits per Set 2. Celltrion COVID-19 Self-Check Kit *FDA Certiticates. (1) Home Use : MOQ : 100,000 Kits $8.00/Kit --> 2 Kits per Set 3. G-Mate(Filosys) Saliva COVID-19 Self-Test Kit * Accuracy : +98% * MOQ : 1,000,000 Kits (1) $3.0 / Kit : 25 test kits per box (2) $3.2 / kit : 1 test kit per box 4. ND Force Saliva COVID-19 Self-Test Kit * Accuracy : ±94% * Recently approved by German FDA. * CFS(Certificates of Free Sales) can be provided direcctly from German FDA. * 1 Kit per Set. - MOQ 100,000 Kits : U$2.60 - MOQ: 500,000 Kits : U$2.50 - MOQ: 1,000,000 Kits : U$2.30 Look forward to your PO. Sincerely, Andrew. Kim CentZone Oversea Sales
GENEDIA W COVID-19 Ag (Saliva) 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
Application Suspected case test in epidemic area Early test of fever clinic and CDC Screening of primary medical institutions Inspection of floating population in public areas Performance Characterisitics Sample tyep: nasal swab Time to result: 15-20 minutes Sensitivity: 97.70% Specificity: 99.84% Accuracy:98.97% Layperson study statistics 99.84% of non-professionals carried out the test without requiring assistance 99.82% of different types of results were interpreted correctly. Parameters: A Short Test Time: 15 mintues B Accuracy: More than 98.1% C Sensitivity: 96.4% Specificity: 100% D Easy operation: Nasal Swab E One Step solution F Lower cost with high efficiency G Package: 1 Test/Kit, 5 Tests/Kit, 25 Tests/Kit H It can detection for Omicron Virus
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 - Nasal Swab based - Qualitative - IVD (Invitro diagnostic medical device) - Rapid immunochromatographic assay - 12 Minutes 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
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
Hello, we are a manufacturer in China There are 40,000 square meters of factory Welcome friends to visit If you want to buy, please contact us thanks The current SARS-COV-2 ANTIGEN RAPID SELF TEST KIT currency has 1/box, 5/box, 20/box Support small batch export (declaration of special items through China) Support mass customization Support exporting large boards Contact us for detailed pricing Looking forward to your contact
Nasal and antibody covid 19 test kit
CORONAVIRUS (COVID-19) TEST KITS, * SARS-CoV-2 OneStep RT-PCR Kits (S-Gene), * SARS-CoV-2 OneStep RT-PCR Kits (S-ORF1ab-Gene),
Temperature Block Temperature Range: 0 - 105 Max. Heating Rate: 7 /s Max. Cooling Rate: 5 /s
We are supplying FDA's EUA approved Covid 19 Test Kit to the US. Our COVID-19 Detection Kit is a real-time PCR based in-vitro diagnostic product intended for detection of the novel coronavirus SARS-CoV-2 (COVID-19) RNA in sputum, bronchoalveolar lavage, oropharyngeal or nasopharyngeal smears collected from patients with suspect viral infection The kit is composed of Internal Positive Control (IPC), to monitor appropriate performance of amplification and detection of the kit. Accurate detection of the viral RNA is confirmed parallelly by using Positive and Negative controls which are composed in the kit
Clinitest OTC covid test kits (by Siemens) - FDA approved for use in the USA - Capacity to supply 5M per week - 50% payment up front, then the remaining 50% after the airway bill and packing slip are provided
CORONAVIRUS (SARS COV-2) ANTIGEN DETECTION KIT - Price 2.99 USD ONLY FOB Netherlands Remaining Qty: 60,000 pcs
SOFTEC COVID-19 Antigen Rapid Test (Nasal) The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV 2 nucleocapsid antigens in nasal swabs from individuals with suspected COVID-19 by health care providers. Results are for SARS-CoV-2 nucleocapsid antigen identification. The COVID 19 Antigen Rapid Test Cassette (Nasal Swab) is intended for use by medical professionals or trained operators experienced in performing lateral flow tests. The price of the product is determined by the number of orders.
The COVID-19Antigen Rapid Test Cassette (Saliva) is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in saliva from individuals who are suspecte of COVID-19 by their healthcare provider. There are single pack and 25pcs products (SOFTEC COVID-19 Antigen Rapid Test (Saliva)25pcs Pack). The price of the product is determined by the number of orders.
Rapid Accurate Innovative Comfortable Lollipop style Integral This SARS-CoV-2 Antigen Kit (Saliva Pen) is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in saliva specimens from individuals who are suspected of COVID-19. The most suitable for over-the-counter (OTC) home use by laymen in a non-laboratory setting. The most widely used testing scenarios, like for school kids test. The most integral design, simple and easy use lollipop style. The fastest result deliver: result is available within only 15 minutes. Cat.No Description Package size CG123201 Goldsite SARS-CoV-2 Antigen Kit(Saliva Pen) 1T CG123207 Goldsite SARS-CoV-2Antigen Kit(Saliva Pen) 7T CG123225 Goldsite SARS-CoV-2Antigen Kit(Saliva Pen) 25T
Korean made Gmate COVID-19 Saliva Antigen Test Kit is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human saliva specimens. This test is an aid to early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms with SARS-CoV-2 infection. â?¢ 90.9% Sensitivity, 100% Specificity â?¢ Made in Korea â?¢ Easy to Use â?¢ Currently the only imported brand approved and fully registered with governments and medical / health agencies for professional and home use. Provides initial screening result only Disclaimer: Reactive specimens must be confirmed with alternative testing method(s)
We Supple Grade A medical examination Disposable Covid-19 test kit and Syringes with affordable prices in major international market free to contact us for more Quotation.
NanoCare COVID-19 Antigen (Ag) Kit is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.
