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China

Intended Use COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitativedetection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test provides only a preliminary result forself-testing. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmedwith alternative testing method(s) and clinical findings. Features ·For self-testing use ·Results ready in 15 minutes ·Accurate diagnostic tool for active infection·Easy to administer and read results ·Affordable, no need for instrument, highly portable ·Enable testing on a massive scale COVID-19 Positive: lf the C and T band is present, the test indcates for the presence of COVID-19 (SARS-Cov-2) antigen in the specimen.The result is COVID-19 positive.

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United Kingdom

Sugentech SGTi-flex COVID-19 Ag is an immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimen. • Specimen: Nasopharyngeal (or Nasal) swab • One Step, Fast results within 15 min • Full package for the whole test procedure, No need for additional tool/device - Swab - Buffer - Test Cassette • Package: 5 test kits *all prices are ex vat * shipping is free on orders over 1000 units to one location Product No. CAGT001E0 Description COVID-19 Antigen Lateral Flow Test. For self-testing only. Approvals CE Marked, MHRA registered Intended Use An immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimen. Accuracy Overall Accuracy Sensitivity Specificity 97.35% 95.07% 99.38% Package Each test is individually boxed Specimen Nasal Swab Storage 2-30 Celsius Test Time 15-30 minutes CE Marked US FDA MHRA Compliant European Commission

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United Kingdom

The Humasis COVID-19 Test is an in vitro diagnostic test based on lateral flow chromatographic immunoassay intended for qualitative detection of SARS-CoV-2 antigen in human nasopharynx. For healthcare professional use in near patient testing environments. Sensitivity 95.5% & Specificity 100% Kit Contents ▪ 1 x Test devices packaged individually in aluminium pouch ▪ 1 x Disposable test tubes with extraction buffer ▪ 1 x Filter caps ▪ 1 x Sterilised swabs for specimen collection ▪ 1 x Instructions for use *All prices are ex vat *£2 ex vat per test * shipping is free for orders over 1000 units

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United Kingdom

Sugentech SGTi-flex COVID-19 Ag is an immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimen. • Specimen: Nasopharyngeal (or Nasal) swab • One Step, Fast results within 15 min • Full package for the whole test procedure, No need for additional tool/device - Swab - Buffer - Test Cassette • Package: 1 test kit *all prices are ex vat * shipping is free on orders over 1000 units to one location Product No. CAGT001E0 Description COVID-19 Antigen Lateral Flow Test. For self-testing only. Approvals CE Marked, MHRA registered Intended Use An immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimen. Accuracy Overall Accuracy Sensitivity Specificity 97.35% 95.07% 99.38% Package Each test is individually boxed Specimen Nasal Swab Storage 2-30 Celsius Test Time 15-30 minutes CE Marked US FDA MHRA Compliant European Commission

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United Kingdom

Sugentech SGTi-flex COVID-19 Ag is an immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimen. • Specimen: Nasopharyngeal (or Nasal) swab • One Step, Fast results within 15 min • Full package for the whole test procedure, No need for additional tool/device - Swab - Buffer - Test Cassette • Package: 2 test kits *all prices are ex vat * shipping is free on orders over 1000 units to one location Product No. CAGT001E0 Description COVID-19 Antigen Lateral Flow Test. For self-testing only. Approvals CE Marked, MHRA registered Intended Use An immunoassay for qualitative detection of Nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimen. Accuracy Overall Accuracy Sensitivity Specificity 97.35% 95.07% 99.38% Package Each test is individually boxed Specimen Nasal Swab Storage 2-30 Celsius Test Time 15-30 minutes CE Marked US FDA MHRA Compliant European Commission

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Netherlands

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Diagnostic Automation offers a One-Step Malaria Rapid diagnostic Test for Malaria pf and pv antigens. This Malaria Rapid Test is a rapid, qualitative test for the detection of Plasmodium falciparum and/or Plasmodium vivax in whole blood. For the rapid qualitative determination of Malaria P. falciparum pecific histidine rich protein-2 (Pf HRP-2) and Malaria P. vivax specific lactate dehydrogenase (pvLDH) in human blood as an aid in the diagnosis of Malaria infection. Diagnostic Automation offers two formats of the Malaria Rapid Test.

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Netherlands

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Diagnostic Automation offers a One-Step Malaria Rapid diagnostic Test for Malaria pf and pv antigens. This Malaria Rapid Test is a rapid, qualitative test for the detection of Plasmodium falciparum and/or Plasmodium vivax in whole blood. For the rapid qualitative determination of Malaria P. falciparum pecific histidine rich protein-2 (Pf HRP-2) and Malaria P. vivax specific lactate dehydrogenase (pvLDH) in human blood as an aid in the diagnosis of Malaria infection. Diagnostic Automation offers two formats of the Malaria Rapid Test.

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Netherlands

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Ce simple test salivaire permet de détecter la consommation de 6 drogues différentes en même temps. Il s'agit des drogues suivantes : - Cocaïne - Amphétamine - Cannabis (herbe, haschich) - Opiacés (héroïne, morphine, codéine) - Méthamphétamines - Fenciclidine. Le test salivaire multi-drogues se base sur le principe des réactions immunochimiques rapides entre les antigènes et les anticorps, qui sont utilisés lors de la recherche de substances spécifiques dans la salive. En règle générale, les traces de drogues dans la salive après la dernière utilisation peuvent être détectées dans les délais suivants : Amphétamines, Méthamphétamines : de 5-10 minutes à 72 heures. Cocaïne : de 5-10 minutes à 24 heures. Opiacés : codéine utilisée par voie orale 7-21 heures, morphine (métabolites de la codéine et de l'héroïne 24-48 heures). Cannabis : jusqu'à 14 heures après la dernière consommation. Fenciclidine : dépend de la quantité utilisée.

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China

[Product Name] Generic Name: Alpha-fetoprotein (AFP) assay kit (ELISA) [Pack size]: 48 tests / kit, 96 tests / kit [Intended Use]: The Alpha-fetoprotein (AFP) assay kit is intended for quantitative determination of the Alpha-fetoprotein (AFP) concentration in human serum. [Introduction]: Alpha-fetoprotein (AFP) is a kind of embryonal single polypeptide which synthesized by embryo liver, yolk sac and gastrointestinal tract. Human AFP belongs to the alpha globulin, composed of 18 kinds of amino acids. The molecular weight of AFP is about 64 KD ~ 72 KD with a half-life of about 5d. Part of AFP can enter into the maternal blood circulation as amniotic fluid, AFP levels in body fluids of pregnant women all have a different enhanced. Normally, non-pregnancy women have lower concentration of serum AFP. Liver cancer is one of common reasons that induce abnormally increase of AFP.

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China

[Product name] Bacterial Vaginosis Quick Test Kit (Sialidase Detection) [Packing size] 20 pcs/kit; 50 pcs/kit [Intended use] For qualitatively testing activity of neuraminidase in female’s vaginal fluid, only for auxiliary diagnosis of bacterial vaginosis. [Testing principle] Neuraminidase is one of pathogenic factors of bacterial vaginosis (BV). Activity of neuraminidase in vaginal fluid of BV women is significantly higher than that in vaginal fluid of normal women; there is no or only a small amount of neuraminidase in vaginal fluid of normal women. By testing for neuraminidase higher than normal level in the vaginal fluid, patients can be diagnosed whether have BV. This kit mainly contains bacterial neuraminidase-specific chromogenic substrate solution.

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China

This kit is used for the quantitative determination of Luteinizing Hormone (LH) in human urine samples in vitro. Human luteinizing hormone (LH) is a kind of glycoprotein hormones secreted by the pituitary gland, exists in human blood and urine, its role is to stimulate the release of the ovaries mature eggs. LH in the middle of the menstrual secretion, sharply form LH peak, from the basic level of 5 ~ 20 miu/ml rapidly rising to the peak of 25 ~ 200 miu/ml.Urine LH concentration is usually about 36 ~ 48 hours before ovulation suddenly jumped sharply, in 14 ~ 28 hours peak, peak about 14 to 28 hours after theca burst, mature eggs. LH within two days after ovulation back to the basic level, to enter the luteal phase, luteal phase usually lasts for 14 days. Then, the new follicles began to development, into the next menstrual cycle, so the cycle, until the pregnancy. Women in the LH peak within 1 ~ 3 days after the most fertile.

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China

The test kit is used for the quantitative determination of procalcitonin (PCT) in human serum, plasma or whole blood samples in vitro. Procalcitonin (PCT) is the prohormone of calcitonin (CT), which is generally less than 0.1 ng/mL in the blood of healthy people, and its secretion increases after being stimulated by pro-inflammatory responses, especially after bacterial infection. Procalcitonin is an important marker that can specifically distinguish bacterial infection from inflammatory response caused by other reasons. Viral infection, allergy, autoimmune disease and transplant rejection do not cause significant elevation of procalcitonin, while local bacterial infection can result in moderate elevation of procalcitonin concentrations. In some cases (neonatal, multiple trauma, burns, major surgery, prolonged or severe cardiogenic shock), the elevation of procalcitonin may not be related to infection and usually returns to normal values quickly.

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China

[Intended use] HBsAg Test kit (Colloidal Gold) is used for qualitative detection of Hepatitis B surface Antigen in human serum or plasma samples. Hepatitis B surface Antigen (HBsAg) is the hepatitis b virus coat protein. It's not contagious, only the antigenicity. But it is usually accompanied by the presence of hepatitis b virus, so it is a sign of the hepatitis b virus infection. [Test principle] HBsAg Test kit (Colloidal Gold) uses colloidal gold immune chromatography technology to qualitative detection of Hepatitis B surface Antigen in human serum or plasma samples.

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Switzerland

COVID-19 Test kit Bioteke has developed the COVID-19 antigen test cassette 3in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. Rapid tests are individually packaged and are therefore ideally intended for quick use. The special features are the easy sampling, easy to read and clearly displayed results and the result is available even after 15-20 minutes. Technical specifications Bioteke Pack • 20 pack Carton • 25 boxes – 500 pieces Standards – and market conformity • Professional application (only for professional use) • Rapid test 3 in 1 • TÜV Süd EN ISO 13485:2016 • BFarm number: AT082 / 20 • CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance TestV • 97.6% sensitivity • 98.

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China

Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR) is used for the detection of nucleic acid from monkeypox virus in serum and human pustular or vesicular rash specimens from individuals suspected of monkeypox virus infectious. By specifically detecting the nucleic acid fragments of monkeypox virus, monkeypox virus can be quickly identified, which is suitable for rapid diagnosis of related diseases caused by monkeypox virus infection.

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China

it is intend for qualitative determination of LH levels in women urine to predict ovulation time, so as to guide reproductive women to choose the optimal conception time or safe period contraception. Luteinizing Hormone(LH)Ovulation Test Kit based on the principle of colloidal gold labeling technique and immune chromatography of double-antibody sandwich method. During testing , the LH in urine specimen migrates via capillary action along the membrane to react with LH monoclonal antibody conjugated with nanoscale colloidal gold particles forming an antibody-antigen complex.

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China

It is intend for qualitative determination of FSH levels in women urine. It provides some useful information for women who will prepare for pregnancy or focus on ovarian health, functions and fertility, also assists the diagnosis and treatment of pituitary and gonadal dysfunction. Follicle Stimulating Hormone(FSH) Test Kit (Colloidal Gold) is based on the principle of colloidal gold labeling technique and immune chromatography of double-antibody sandwich method. During testing, the FSH in urine specimen migrates via capillary action along the membrane to react with FSH monoclonal antibody conjugated with nanoscale colloidal gold particles forming an antibody-antigen complex.

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China

Monkeypox virus IgG/IgM Test Kit (Immunochromatography) is a solid phase immunochromatographic assay for the rapid, qualitative detection of IgG/IgM antibody to Monkeypox virus in human blood. This test provides only a preliminary test result. Therefore, any reactive specimen with the Monkeypox virus IgG/IgM Test Kit (Immunochromatography) must be confirmed with alternative testing method(s) and clinical findings.

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China

IIntended Use Singclean Flu A/B Antigen Test Kit is an in vitro qualitative detection that uses colloidal goldimmunochromatography to test influenza A/B antigen in nasopharyngeal swab samples obtained from patients with signs and symptoms of respiratory infection in just 15 minutes. lt is designed to give rapid and reliable test results on the spot without any laboratory equipment. This allows early start of treatment,which helps reduce the duration and severity of the disease,Besides,detection of influenza reduces unnecessary use of antibiotics and aids in limiting thespread of the infection. Advantages a. Easy to operate: All components include in kit,no additional equipment orlaboratory resources required; b.Fast detection: 15 minutes to interpret the result after collecting specimen; c.Joint testing: Influenza A and B can both be tested in one reagent; d.Accurate,Rapid,Sensitive Positive: Positive influenza A and B:Line C, Line A and Line B allappeared.

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China

The novel coronaviruses belong to the βgenus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection: asymptomatic only infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

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China

Singclean Multi-Drug One Step Test Kit is used to qualitatively detectwhether there are drugs or drug metabolites in the urine of targetpeople,and conduct preliminary screening for target drug users withcolloidal gold method. lt is for the detection of 23 drugs like COC、AMP、MOP、THC、MET、OPI、BAR、BZO、MTD、MDMA、TCA、OXY、BUP、PCP、EDDP. ldeal for: 1.Pre-employment drug screening 2.Random drug testing 3.Medical clinic drug testing 4.Reasonable suspicion drug tests 5.Substance abuse screening in hospitals How much sample do I need? 1. Cassette format: need 3 drops of urine sample(about 100uL). 2. Panel format: lmmerse the test panel verticallyinto the urine specimen for at least 10-15 secondsor until migration occurs.mmerse the strip(s) atleast the level of the wavy lines, but not above thearrow(s) on the test card. 3.Cup format: fill the Drug Test Cup with urine to at least the minimum fill level line. POSITIVE Only one colored band appears in the control region (C)

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China

Monkeypox virus Antigen Test Kit (Immunochromatography) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to Monkeypox virus in human body fluid. This test provides only a preliminary test result. Therefore, any reactive specimen with the Monkeypox virus Antigen Test Kit (Immunochromatography)must be confirmed with alternative testing method(s) and clinical findings.

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China

The novel coronaviruses belong to the βgenus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection: asymptomatic only infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

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Switzerland

COVID-19 Test kit Testsealabs has developed the COVID-19 antigen test cassette 3in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. Technical specifications Testsealabs • 1 Box / 25 pack • Professional application (only for professional use) • Rapid test 3 in 1 • Approved in Germany • TÜV Süd EN ISO 13485:2016 • BFarm number: AT082 / 20 • CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance (TestV) • 97.6% sensitivity • 98.4% specificity • With a separate buffer solution

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Switzerland

COVID-19 Test kit Greentspring has developed the COVID-19 antigen test cassette 4 in1 for quick detection. The COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Covid-19 antigen in the lolli, nasopharynx, oropharynx and nasal swabs, to support the diagnosis of a Covid-19 virus infection. Technical specifications Greenspring • 1 Box / 25 pack • Professional application (only for professional use) • Rapid test 4 in 1 • Approved in Germany • EN ISO 13485:2016 • BFarm number: AT417/20 • CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance (TestV) • 96.77% sensitivity • 100% specificity • With a integrated buffer solution

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Turkey

The Sentebiolab Senteligo™️ SARS-CoV-2 (COVID-19) Multiplex qPCR Detection test includes a Primer-Probe set inside the Reaction Mix that contains primers and probes for human RNaseP and viral N1 and N2 regions. The internal control (primer/probe set for human RNaseP gene) is used to identify possible qPCR inhibition, confirm the integrity of the reagents, and verify the quality of RNA extraction from patient material. RNaseP primers and probes included in the kit recognize the human RNaseP gene. The primers and probes for viral N1 and N2 regions specifically identify two distinct regions on the nucleocapsid (N) gene of the SARS-CoV-2 virus. These primers and probes do not recognize the SARS-CoV virus, whose genetic structure is highly similar to SARS-CoV-2.

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Germany

Easy to use with results in 15 minutes Reliable with a specificity of 99.2% and a sensitivity of 96.1% BfArM listed and evaluated by the PEI (Paul Ehrlich Institute). CE-certified as a self-test for self-use

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China

This product is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs that are self-collected by an individ-ual aged 18 years or older or are collected by an adult from an individual younger than 18 years old. This test is intended for use in individuals with symptoms or other epidemiological reasons to suspect a COVID-19 infection. This product is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection

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