Brand: Innovita FDA CE German lots of country approval and certs
Made in Germany German Brand Antigen Rapid Test Kit MP Bio Antigen selftest detection kit - COVID-19 is a true COVID-19 self-diagnostic test capable of detecting the presence of viral antigens in nasal samples within 15 minutes.
COVID-19 Antigen Rapid Test (Saliva Lollipop) is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in Saliva samples from individuals suspected of COVID-19. Welcome to inquiry.
1. Wisetest Salvia Home 1-test- and 5-test-kit FDA 2. iHealth 2-tests-kit EUA 3. Flowflex 1-test-kit EUA Location: OTG US/Spain Location China: 1-2 days production and air ship worldwide Payment: Full TT or LC at sight
Boson EUA slef testing covid antigen test card, DDP Chicago airport/DDP New York airport. Any interest pls contact us!
Simens EUA self testing Antigen nasal swab test & Flowflex EUA self testing Antigen nasal swab test are availble. DDP USA. Any interest pls contact us
This kit is used to qualitatively detect in vitro suspected cases of pneumonitis infected by a new type of coronavirus. The PCR reaction solution contains 2 sets of specific primers and fluorescent probes for specific detection of targets, and an additional set of specific primers and fluorescent probes is used as the internal standard control of the kit for detecting endogenous housekeeping genes. Lowest detection line:200copy/mL Specificity: this kit has no cross-reaction with hepatitis B virus, hepatitis C virus, staphylococcus aureus, gram-positive bacteria, shigella bacillus, influenza A, influenza B, enterovirus and human genome DNA/RNA. Precision reference products: After repeated 20 times, the amplified Ct CV of each fluorescence channel was no more than 5%.Ct CV 5%
This is our new product, it is non cold chain transport , it more convenient for transportation and it will be reduce shipping costs. Product performance index 1.Lowest detection line:200 copies/mL Compliance rate of negative reference: 10 negative references were tested, and the test results were all negative; 2.Specificity: this kit has no cross-reaction with hepatitis B virus, hepatitis C virus, staphylococcus aureus, gram-positive bacteria, shigella bacillus, influenza A, influenza B, enterovirus and human genome DNA/RNA. 3.Precision reference products: After repeated 20 times, the amplified Ct CV of each fluorescence channel was no more than 5%.Ct CV 5%
This kit is intended for qualiativein vitro detection of Orf1ab and N genes of Novel Coronavirus 2019-nCoV which are found in throat swab,sputum and alveolar lavage fuid samples of suspected cases of pneumonia,suspected cases of clustering and other patients who need to carry out diagnosis or differential diagnosis of Novel Coronavirus 2019-nCoV infection.
The disposable virus sampling tube/Virus Transport Medium(VTM) is suitable for nucleic acid extraction of SARS-CoV-2 virus, various influenza viruses, avian influenza viruses, rubella, swine fever and other virus samples. The disposable virus sampling tube/Virus Transport Medium(VTM) is suitable for nucleic acid extraction of SARS-CoV-2 virus, various influenza viruses, avian influenza viruses, rubella, swine fever and other virus samples. It is also suitable for the collection and transportation of specimens of Chlamydia, Mycoplasma, and Mycoplasma Arthroplasma. Samples are usually collected from the mouth, throat, nasal cavity, and anus. Sampling tube: The tube body and tube cover are made of polypropylene, which will not deform at high temperature and high pressure (121C, 15min), and will not become brittle at low temperature (196C). Resistant to static extrusion and dynamic impact. The bottom tapered design is resistant to centrifugation and vibration. Built-in sample preservation solution is used for sample preservation to prevent leakage. Sample preservation solution: Functioned with virus lysis solution and virus nucleic acid preservation solution. The virus lysate realizes the inactivation of the virus in the sample and reduces the risk of secondary infection. The unique protection system can prevent nucleic acid from being degraded and improve the accuracy of downstream detection. The sample has a wide adaptability and can be used for the collection, preservation and transportation of various swabs. Sampling swabs: sampling swabs are flocking sampling heads, which are non-toxic to cells and viruses, and do not contain RNase, which can greatly increase the collection and release of virus samples , ensure the accuracy of PCR detection results. The plastic rod is made of ABS, with a unique molded breaking point design, and there is no tiny debris during the breaking process. Features: 1.More collection and release:nylon flocked swabs provide optimum specimen collection because of their ability to collect more specimen at the collection site and to more rapidly release the entire samples specime 2. High safety factor: it can lyse pathogens, inactivate viruses, and reduce the risk of secondary infection. 3. Stable nucleic acid: a unique protection system that can prevent nucleic acid from being degraded and improve the accuracy of downstream detection. 4. Wide sample adaptability: it can be used for the collection, preservation and transportation of various swabs,Including oral swabs, throat swabs, nasal swabs, vaginal swabs and so on.
[Intended Usage] This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites. [Storage Conditions & Validity] 1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box. 2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times. 3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period. [Applicable Instruments] 1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument. 2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support. NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels. [Sample Requirements] 1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices. [Test Results Interpretation] 1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements. 2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition. 3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample. [Product Performance Index] 1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%. 2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%. 3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL. [CE Mark Registration No.]: RPS/499/2021. [EC REP.]: CMC MEDICAL DEVICES & DRUGS S.L. C/ Horacio Lengo n18, C.P 29006, Milaga, Spain.
INTENDED USE For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection. FEATURES Coated with carefully selected specific Nucleocapsid and Spike protein antigen. Detection for IgM and IgG antibodies simultaneously. Simple operation, easy result interpreted. Rapid test within 15 minutes. RESULTS INTERPRETATION Positive: 1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies. 2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody. 3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody. Negative: 1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative. Invalid: 1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested. 2. The test result is invalid after 15 min. CLINICAL PERFORMANCE - Positive Percent Agreement (PPA) = 91.07% (153/168) (95% CI: 85.70%-94.92%). - Negative Percent Agreement (NPA) = 95.37% (103/108) (95% CI: 89.53%-98.48%). - Overall Rates of Agreement (ORA) = 92.75% [(153+103)/ (168+108)] (95% CI: 89.03%-95.52%). [Product Name]: SARS-CoV-2 IgM/IgG Duo Test [Product Code]: Cat# FP-319 [Sample Type]: Whole blood /Plasma/Serum [Sample Volume]: 20L /10L/10L [Detection Method]: Colloidal Gold [Reaction Time]: 10-15min [Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL. [Storage Condition]: 2oC ~ 30oC [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/499/2021.
Our covid-19 antigen saliva test and covid 19 ag swab test already got Germany BFARM number and passed PEI test, and antigen nasal test has been registered on EU common list, hope to cooerate with your esteemed company, self testing is on progress. Hope to cooperate with your esteemed company, and we got very good feedback from many clients, promise you high quality.
The COVID-19 RT-PCRT est is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test can be run in a singleplex format (three individual assays) or multiplexed into a single reaction and amplification set up.
20 tests/box
covid antigen nasal rapid test passed the Germany PEI testing and registered on EU Common List
20 tests/box, 1 pcs/box, 5pcs/box
Covid Ab IgG/IgM Ab Whole blood test device Covid Antigen Ag swab rapid test card Covid Antigen Ag saliva rapid test card
* KOREA Brand : 1) GenBody 2) ASAN PHARAM 3) SD BIOSENSOR 4) BIOCREDIT 5) Wells Bio * Test Type : IgG/IgM Antigen, antibody test * Accuracy rate : 92%~95% * Read result time : 5~10 mins * Package : 25 kit + 1 Reagent / 1 box * Price : FOB Korea 8.5 ~ 10.5 USD / 1 kit * MOQ : 10,000 KIT * Payment Terms : T/T 50% advance and Balance SGS inspection * Product Certificate : KFDA, CE, FDA
* KOREA Brand : 1) OSANG HealthCare 2) SD BIOSENSOR 3) Genematrix * Test Type : RT-PCR * Accuracy rate : 98% * Read result time : One and half hour ~ * Package : 96 test or 100 test / 1 Kit, 1 box * Price : FOB Korea 1,300 ~ 1,650 USD / 100 test * MOQ : 10,000 test * Payment Terms : T/T 50% advance and Balance SGS inspection * Product Certificate : KFDA, CE, FDA
