Search Filters

Search Results

Found 11 results

510(k) Data Aggregation

    K Number
    K130275
    Device Name
    QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2013-09-26

    (234 days)

    Product Code
    DJG, LAF, SEP
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QuikScreen™ Multi (MDMA and OPI) Drug Cup Test consists of competitive binding , lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for OTC and prescription use.
    Device Description
    QuikScreen ™ Multi (MDMA and OPI) Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder, which is able to hold the Strip of MDMA and OPI within the container. The membrane of the MDMA test strip is coated with goat anti-mouse antibody and MDMA-Bovine serum albumin conjugate. The membrane of the OPI test strip is coated with goat anti-mouse antibody and OPI-Bovine serum albumin conjugate. The sample pad of the MDMA test strip contains a colloidal gold-labeled mouse monoclonal anti-MDMA antibody. The sample pad of the OPI test strip contains a colloidal gold-labeled mouse monoclonal anti-OPI antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of drug (500ng/ml of MDMA or 300ng/ml of OPI), Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A color line will always appear at the control region. A negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the test result shows 1 line (preliminary positive) you should send the sample for laboratory testing.
    Ask a Question
    K Number
    K122064
    Device Name
    FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2013-05-07

    (298 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ForSure One Step Buprenorphine Drug Cup Test Device is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at cutoff level of 10 ng/mL. The test is intended for prescription and overthe-counter use. The buprenorphine assay will yield preliminary positive results when buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The ForSure One Step Buprenorphine Drug Cup Test Device shows the drug was or was not present at the cutoff level. The assay provides only a preliminary analytical test result. A more specific alternative 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) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
    Device Description
    ForSure" One Step Buprenorphine Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder which is able to hold the QuikStrip of Buprenorphine within the container. The membrane of the test strip is coated with goat anti-mouse antibody and Buprenorphine-Bovine serum albumin conjugate. The sample pad contains a colloidal gold-labeled mouse monoclonal anti-Buprenorphine antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml of Buprenorphine. Unbound colloidal gold labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A Negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to visually read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the Buprenorphine result shows 1 line (preliminary positive) you should send the sample for laboratory testing.
    Ask a Question
    K Number
    K112449
    Device Name
    QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2012-09-24

    (396 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.
    Device Description
    The device consists of a plastic housing and test stick containing an immunochromatographic strip. The test pad contain colloidal gold conjugate with mouse monoclonal antibodies against beta subunit of hCG and test strip contain mouse monoclonal antibody against alpha subunit of hCG ( test line )and goat antimouse polyclonal antibodies ( Control line ). The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine, in some cases as early as 3 days before the expected period.
    Ask a Question
    K Number
    K071489
    Device Name
    HOMECHECK MULTIPLE DRUG CUP TEST
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2008-03-28

    (303 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, DJR, JXM, LCM, LDJ, LFH
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant. This test is intended for over the counter (OTC) consumer use as the first step in a 2-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding the confirmatory testing - the second step in the process-, along with materials for shipping the urine specimen to the laboratory is included with the test. There are no uniformly recognized levels for Benzodiazepine, Oxycodone, Tricyclic Antidepressant, and Barbiturates. The test is not intended to screen individuals who are prescribed these drugs by a physician; the test my yield positive results for individuals taking such drugs, as prescribed.
    Device Description
    New Bay HomeCheck Rapid Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000ng/ml of Amphetamine, 1000ng/ml of Methamphetamine, 50ng of THC, 2000ng/ml of Morphine, 300ng of Benzoylecognine, 25ng/ml of Phencyclidine, 300ng/ml of Benzodiazepine, 300ng/ml of Methadone, 100ng/ml of Oxycodone, 1000ng/ml of Tricyclic Antidepressant, and 300ng/ml of Barbiturates. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
    Ask a Question
    K Number
    K073431
    Device Name
    FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2008-01-14

    (39 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K061617
    Device Name
    FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2006-11-22

    (166 days)

    Product Code
    DKZ, DIO, DJG, DJR, DJS, JXM, JXN, LCM, LDJ, LFG
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels: Test: Amphetamine, Calibrator: D-Amphetamine, Cutoff: 1000 ng/ml Test: Methamphetamine, Calibrator: D-Methamphetamine, Cutoff: 1000 ng/ml Test: Benzodiazepine, Calibrator: Oxazepam, Cutoff: 300 ng/ml Test: Barbiturate, Calibrator: Secobarbital, Cutoff: 300 ng/ml Test: Cocaine, Calibrator: Benzoylecgonine, Cutoff: 300 ng/ml Test: Cannabinoids, Calibrator: 11-nor-delta9-THC-9 COOH, Cutoff: 50 ng/ml Test: Opiates, Calibrator: Morphine, Cutoff: 2000 ng/ml Test: Phencyclidine, Calibrator: Phencyclidine, Cutoff: 25 ng/ml Test: Methadone, Calibrator: Methadone, Cutoff: 300 ng/ml Test: Oxycodone, Calibrator: Oxycodone, Cutoff: 100 ng/ml Test: Tricyclic Antidepressant, Calibrator: Nortriptyline, Cutoff: 1000 ng/ml Test: Propoxyphene, Calibrator: Propoxyphene, Cutoff: 300 ng/ml This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
    Device Description
    Forsure One Step Dip & Read Drug Screen Test consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine, 1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine, 300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone , 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A PRELIMINARY POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
    Ask a Question
    K Number
    K052520
    Device Name
    RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2006-04-24

    (222 days)

    Product Code
    DJG, DIO, DKZ, DPK, LCM, LDJ
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
    Device Description
    New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
    Ask a Question
    K Number
    K052882
    Device Name
    FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2006-02-15

    (126 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFH
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Forsure One Step Single or Multiple (X) Drug Screen Strip of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene Test device are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml . Phencyclidine at a cutoff concentration of 25 ng/ml, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.
    Device Description
    New Bay Forsure Rapid One Step Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone, 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
    Ask a Question
    K Number
    K052208
    Device Name
    GLUCOSE PILOT
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2005-12-09

    (119 days)

    Product Code
    NBW, CGA, JJX
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glucose Pilot Blood Glucose monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from a finger stick, for the lay-user. It is also intended for the professional use, which include fresh capillary whole blood. It is intended for use outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
    Device Description
    The Glucose Pilot Glucose monitoring System consists of a hand-held blood glucose meter, test strips, lancing device, lancets, and two levels of control solution. The test strip has a lot - specific calibration information and the meter reads automatically. The meter is turned on by inserting the strip, the user supplies the capillary blood or control solution, the meter makes an audible tone and starts the assay, which completes in five seconds. The meter's software converts the results read off the test strip into a plasma glucose concentration and displays the value on the meter's display. The provided instructions and illustrations explaining that the blood drop will be pulled into the strip sample entry by capillary action. Results are stored in the meter's memory for tracking purposes.
    Ask a Question
    K Number
    K042988
    Device Name
    RAPID ONE STEP BUPRENORPHINE TEST CARD
    Manufacturer
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Cleared
    2005-05-12

    (195 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tianjin New Bay Bioresearch Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Sure One Step Buprenorphine Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
    Device Description
    For Sure Buprenorphine Rapid Test Card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate in whilel the arag of aring membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibodysample from and ages free drug in the specimen forming an antibody-antigen complex. conjugate onlike to the from bilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 will of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen unor color band in the control area. There is no meaning attributed to color produces only one other line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
    Ask a Question

    Page 1 of 2