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The Instant-view-plus™ Immunochemical Fecal Occult Blood Test is a qualitative immunoassay for detection of Fecal Occult Blood. It is intended for professional and over the counter use.

This device is a Driven Flow™ chromatographic immunoassay consisting of a test strip housed in a plastic cassette.

The Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs. These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

The Instant View® Multi-Drug Urine Test Cup (Home Use) and the Instant View® Multi-Drug Urine Test Panel (Home Use) are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to thirteen individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug.

The Instant View® Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below. The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results. The Instant View® Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below. The drug tests will provide a preliminary result only. A more specific. alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.

The Instant View® Multi-Drug of Abuse Urine Test Cup and the Instant View® Multi-Drug of Abuse Urine Test Panel are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to twelve individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundycolored band during the test regardless of the presence of the drug.

The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use. Analyte | Calibrator | Cutoff ---|---|--- Morphine/Opiates | Morphine | 300 ng/mL Oxycodone | Oxycodone | 100 ng/mL Oxycodone | Oxycodone | 300 ng/mL This assay provides only preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to three (3) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a colored band during test regardless of the presence of the drug.

The INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.

Device is a one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with mouse anti-human hemoglobin monoclonal antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti-human hemoglobin antibodies, and the C line is coated with goat anti-mouse IgG antibodies. The proposed device has only cassette format. The cassette is a device that contains a dip-strip in a plastic housing.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of amphetamine in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only. The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of cocaine (benzoylecgonine) in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only. The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of methamphetamine in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only. The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only. The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only. The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for health care professional including point of care use. The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for home use. The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 100 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, tricyclic antilegressant in urine. The malti-drug of absoce wine test device shows the drug was not present at the cutoff level. This test provides only a preliminary result. A more specifical nethod must be used in order to obtain a confirmed analy. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liguid Chromatography (HPLC) is the preferred confirmatory nethod. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-amphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with amphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody. This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti- benzoylecgonine (cocaine) antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with benzoylecnine-BTG, and the C line is coated with goat anti-rabbit This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-methamphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with methamphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody. This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody. This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody. A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during test regardless of the presence of the drug. A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during test regardless of the presence of the drug.

The proposed BUP/NBUP Urine Test is a qualitative immunoassay for the rapid detection of buprenorphine and norbuprenorphine from human urine specimens. The test provides only a preliminary result. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with Rabbit anti-buprenorphine antibodies and mouse IgG, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with Buprenorphine-BSA, and the C line is coated with goat anti-mouse IgG antibodies.

The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting. The INSTANT-VIEW Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with anti- Troponin I antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti- Troponin I antibodies, and the C line is coated with goat anti-mouse IgG antibodies. The proposed device has two formats: Serum Test and Whole Blood/Serum Test. The Serum Test has two sub-formats: Cassette and Dip Strip. The Whole Blood/Serum Test only has the cassette format. A cassette is a device that assembles a dip-strip in a plastic housing. The studies demonstrate all the formats are equivalent.

The Instant-View H. Pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human blood or serum. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum specimens of adults, 19 years and older.

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. Pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. Pylori antigens, and the C line is coated with goat anti-H. Pylori antibodies.

This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff level of 1000 ng/ml in human urine. It is for health care professional use only. It is for health care professional, in-vitro diagnostic use only. This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1,000 ng/ml in human urine. It is for health care professional use only. Instant-View™ TCA Urine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-TCA antibodies; 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The Test line is coated with TCA- BSA, and the Control line is coated with goat anti-mouse IgG antibody.