According to European standards and FDA EUA lowFlex och Boson
VTM's - Virus Collection & Preservation System Used for universal virus collection and storage in a short time. Class 1
The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. 263a, to perform high complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory specimens during the acute phase of infection. 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 infective status. The agent detected may not be the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. 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 epidemiological information. The COVID-19 RT-PCR Detection Kit is intended for use by qualified trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization. PRINCIPLE OF DETECTION This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel. dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products. Internal reference is used in the kit for quality control starting from sample collection
Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests. This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act. Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization. I. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that: 1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and, 3. There is no adequate, approved, and available alternative to the emergency use of your product. 4 II. Scope of Authorization I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.
Commodity: Covid-19 RT-PCR Detection Kit Spec.96 tests/kit Price:FOB SHANGHAI USD3.30/test, USD316.8/kit $3.60/TEST CIF NY AIRPORT OR OTHER MAJOR AIRPORTS USA OR EUROPE OR S. AMERICA OR MIDDLE EAST Payment: T/T ADVANCE 50% BALANCE BEFORE DEPARTURE OR Sight Irrevocable TRANSFERABLE LC Delivery: By AIR, 50days after receipt and confirmation of LC
Sample Types : Including Nasopharyngeal swab, Oropharyngeal swab, Sputum Controls : Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results Product Information Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate. Authorized Laboratories Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests. About Emergency Use Authorization (EUA) This test (1) has not been FDA cleared or approved, (2) has been authorized by FDA under an EUA for use by authorized laboratories, (3) has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
GENEDIA W COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood. Allow wider testing with fast test time (10 minutes) Perform directly at the point of care High capacity to meet the most urgent medical and public health needs Package Unit : 20 Tests/Kit Expiration Date : 24 Months
GENEDIA W COVID-19 Ag (Nasopharyngeal swab and sputum) 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
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
Introducing our Rapid Malaria Testing Kit, a breakthrough in diagnosing malaria with speed and accuracy. This cutting-edge kit is designed for easy and quick detection of the malaria parasite, revolutionizing the way healthcare professionals identify this life-threatening disease. With a user-friendly approach, it requires only a small blood sample to deliver results within minutes, enabling swift and informed medical decisions. Our kit boasts high sensitivity and specificity, ensuring reliable diagnoses even in low-infection scenarios. Its compact design and portability make it ideal for remote and resource-limited settings. Trust our Rapid Malaria Testing Kit for fast, dependable, and life-saving malaria diagnosis, providing critical support in the fight against this global health challenge.
Our Rapid Typhoid Testing Kit is a cutting-edge solution for swift and accurate diagnosis of typhoid fever. This advanced kit is designed for quick detection of the Salmonella Typhi bacteria, streamlining the diagnostic process for healthcare professionals. With a user-friendly approach, it requires a small blood sample and delivers results within minutes, enabling rapid treatment decisions. The kit exhibits exceptional sensitivity and specificity, ensuring reliable diagnoses even in low-infection scenarios. Its compact, portable design makes it ideal for remote and resource-limited areas. Trust our Rapid Typhoid Testing Kit for fast, dependable, and life-saving typhoid fever diagnosis, enhancing patient care and containment of this infectious disease.
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New Gene Covid19 antigen selftests. 150K available in warehouse in Belgium. Languages : Dutch, French, German, Englisch 25 individual packed tests in a box
Alltest Combo (Flue+Coivd-19) 1:3, hard box, 1 pcs packing, self testing
Offering Alltest Covid 19 antigen + A+B flue, 1:3 combo tests, single packed, self testing, 2 years self time from my warehouse in Vilnius, Lithuania. Good price from authorised Alltest distributor.
Offering Safecare3 Covid 19 antigen + A+B flue, 1:3 combo tests, single packed, self testing, 2 years self time from my warehouse in Vilnius, Lithuania.
Beright brand, oral fluid with CE1434 and self-testing certificate. Stock EU, shipping 3-6 days with DHL economy to any country of Europe.
It is a kit that can easily self-check Covid-19. It has an affordable price and high diagnostic accuracy. - Excellent accuracy and fast reading - Optimized for self-examination with easy and easy procedures - Two-color result display using Nano Band for easy reading - Use nasal swab samples
The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. EUA and CE pass shelf life: 24months since manufacturing date packing:2pcs/box,4pcs/box and so on It is for self testing and OTC, for home use, school , and any group .
The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. View File Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
