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The FIRST RESPONSE® 1-Step Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to four (4) days prior to the expected menses

The device detects the presence of hCG in the urine of a pregnant woman by a series of immunochemical reactions via component reagents striped onto a chromatographic strip contained within plastic housing.

The TROJAN® MINT TINGLE™ Latex Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

The TROJAN® MINT TINGLE™ Brand Latex Condom is a male condom consisting of a sheath of natural rubber latex with a colored pigment and a flavored water-based lubricant. The condom is a straight-walled, nipple-end condom with a nominal length of 180 mm and an approximate width of 52 mm.

The First Response® 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The First Response® I-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the carly diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as three days before the expected period.

The First Response®1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.

The TBD One-Step Ovulation Predictor Test is an at-home in vitro diagnostic use test to be marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human luteinizing hormone (hLH) in urine as an aid in the prediction of ovulation.

The TBD One-Step Ovulation Predictor Test is a simple to use, plastic stick, in vitro device. The top of the stick is clear to allow the user to visualize the migration of the test reagents. The stick contains a chromatographic test strip which has all the necessary reagents to perform the test. An absorbent tip collects and delivers the urine sample to the reagents on the chromatographic strip. The test is performed by placing the absorbent tip into the urine stream for 5 seconds. Alternatively, the test may be performed by immersing the absorbent tip into a container of urine for 5 seconds. The urine sample from the absorbent tip migrates by capillary action along the chromatographic strip, reconstituting the reagents placed strategically along the strip. Visualization of the test results occurs when the appropriate reagents react producing one or two pink-purple lines which appear in a window in the hull of the test stick. The luteinizing hormone (LH) surge is indicated if the test line is similar to or darker than the reference line. If there is no test line or the test line is lighter than the reference line, then there has been no LH surge.

The Brand Name 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The Brand Name 1-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as the first day of the missed menses.

The Brand Name 1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.

for the qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.

The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to Legionella. Purified Legionella pneumopilla antigen (serogroups 1, 2, 3, 4, 5, 6) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.

The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.

The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.