Product Details: Number of Reactions(Preps) per Kit : 100 Brand : Seegene ICMR(Govt) Approved : Yes Test Method : (SARS-CoV-2) RT-PCR Test Time : 2 Hours Cat. No : RP10243X -Detection of COVID-19 specific target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient workow on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer Additional Information: Delivery Time: Immediate
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.
Angiten-COVID-19 Virus Test Kit (Colloidal Gold) Quantity of box: 25 persons/box Brand: Easysweet NMPA (National Medical Products Administration): Approved CE: with CE mark BfArM: listed Test Method: Antigen Test Result Time: 10-15 mins Sample Type: Nasal Swab Sensitivity: 96.70% Specificity: 100% Accuracy: 98.94% Shelf Life: 24 months Storage Temperature: 2-30 Degree Celsius Country of Origin: Made in China Additional Information: Production Capacity: 1 million Delivery Time: 10-15 days Packaging Details: 25 tests in a pack, 40packs/ carton Angiten-COVID-19 Virus Test Kit is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. It can be used by professional only.
COVID-19 RT-PCR TEST - NO RNA PURIFICATION NEEDED! Results in less than 60 minutes, very easy-to-use. Made in USA, with clinical validations all over the world. FDA-EUA approved and CE cleared.
1 test *500BOX/CTN home self test kit MOQ 2000
We can supply the following brand for covid-19 test kits Flowflex ART kits self-testing Boson Test Kits CAS-ENVISION Self test kit MOQ 100,000 kits
SARS COV-2 VARIANTS REAL TIME KIT 5 targets. One single reaction tube per sample. Identification of the main SARS Cov-2 variants of concern, UK, South Africa, Brazil, Nigeria, Indian (Delta). Rapid qualitative detection, 45 minutes. Certified CE IVD Full furniture directly.
.SOFTEC COVID-19 Antigen Test Kit (For Celt Test Use) Fast Easy to Use Reliable The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit designed to detect SARS-CoV-2, the cause of COVID-19, with a self-collected nasal swab sample. The test is intended for use in symptomatic individuals who meet the definition of COVID-19 disease and is limited to asymptomatic individuals who have been in contact with confirmed or suspected cases of COVID-19 and at-risk healthcare workers. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in a human swab sample. There are single packs and 25 pieces of products. SOFTEC COVID-19 Antigen Test Kit (For Self-Test Use) (Pack of 25) The price of the product is determined by the number of orders.
Specimen Collection: Nasal, Saliva Packing: 1 test / 25 Tests Accurancy: >93% Specificy: 99% Warranty: 2 year Certificate: CE, ISO13485,BfArM,BASG,MDA,Thai FDA
COVID-19 Test Kits
Manufacturer: Shanghai LiangRun Biomedicine Technology Co.,Ltd. Certificates: CE(EU), MHRA(UK), HSA(Singapore), MDA(Malaysia), TSE(Turkey), DIGEMID(Peru), Luxus Medical(Germany) , FDA(US), EUA(US, Registering) FOB: 10m, 4.5usd
COVID-19 TESTING KIT title Sample Collection And Preparation. Keep The Kit And Sample To Room Temperature Prior To Testing. Add Sample ( 20 Ul Pf Serum/Plasma/Whole Blood ) To The Sample Well By Using A Micropipette/Dropper. Add Buffer ( 1 Drop For Serum/Plasma Or 3 Drop For Whole Blood ) To The Sample Well Immediately. Wait For The Colored Lines(S) To Appear And Read The Result At 10 Minutes. The Result Is Valid Within 20 Minutes.
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.
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