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The CHECKCUP™ Multi-Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations: | Test | Calibrator | Cut-off (ng/ml) | |---------|-----------------------------------|-----------------| | AMP | d-Amphetamine | 1000 | | BAR | Secobarbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC 150 | Benzoylecgonine | 150 | | COC | Benzoylecgonine | 300 | | MDMA | 3,4-methylenedioxymethamphetamine | 500 | | MET 500 | d-Methamphetamine | 500 | | MET | d-Methamphetamine | 1000 | | MTD | dl-Methadone | 300 | | OPI 300 | Morphine | 300 | | OPI | Morphine | 2000 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-A9-THC-9-COOH | 50 | The CHECKCUP™ Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.

The Ameditech CHECKCUP™ Multi-Drug Test is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in two formats that use identical test strips: Round Cup and Flat Cup. The modified device contains up to seventeen (17) assays that include fourteen (14) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.

The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations: | Test | Calibrator | Cut-off (ng/ml) | |---------|-----------------------------------|-----------------| | AMP | d-Amphetamine | 1000 | | BAR | Secobarbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC 150 | Benzoylecgonine | 150 | | COC | Benzoylecgonine | 300 | | MDMA | 3,4-methylenedioxymethamphetamine | 500 | | MET 500 | d-Methamphetamine | 500 | | MET | d-Methamphetamine | 1000 | | MTD | dl-Methadone | 300 | | OPI 300 | Morphine | 300 | | OPI | Morphine | 2000 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-A9-THC-9-COOH | 50 | The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.

The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in three formats that use identical test strips: Dipcard, Cassette, and Cup. The modified device contains up to seventeen (17) assays that can include up to thirteen (13) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.

The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows. | Test | Calibrator | Cutoff (ng/ml) | |-----------------------------|-----------------|----------------| | Buprenorphine (BUP) | Buprenorphine | 10 | | Propoxyphene (PPX) | Propoxyphene | 300 | | Cocaine metabolite (COC150) | Benzoylecgonine | 150 | This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.

The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative detection of drugs in human urine. This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

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The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows. | Test | Calibrator | Cutoff<br>(ng/ml) | |--------------------------------------------|----------------------------------|-------------------| | Barbiturates (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | 3,4methylenedioxymethamphetamine<br>(MDMA) | 3,4methylenedioxymethamphetamine | 500 | | Methamphetamine (MET1000) | d-Methamphetamine | 1000 | | Methadone (MTD) | Methadone | 300 | | Opiates (OPI300) | Morphine | 300 | | Oxycodone (OXY) | Oxycodone | 100 | This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

The Ameditech ImmuTest Multi-Drug Screen Panel II is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test has three types of test format: card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.

The Ameditech ImmuTest Drug Screen Panel is a one-step panel immunoassay for the qualitative detection of amphetamine, cocaine metabolite (benzovlecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine. The cutoff concentrations for this panel test are amphetamine at 1000 ng/ml, cocaine metabolite at 300 ng/ml, methamphetamine at 500 ng/ml, opiates at 2000 ng/ml, phencyclidine at 25 ng/ml, and THC at 50 ng/ml. This test kit is used to obtain a visual, qualitative results and is intended for professional use.

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The Ameditech ImmuTest™ hCG Pregnancy Test is an In Vitro diagnostic test for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy. The sensitivity of the ImmuTest™ hCG Pregnancy Test is 25 mIU/ml hCG. This test kit is used to obtain a visual, qualitative result and is intended for professional and Over-the-Counter uses.

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The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test for the qualitative detection of opiate metabolites in human urine at cut-off concentration of 2000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

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The Ameditech ImmuTest™ Drug Screen AMPHETAMINE is an In Vitro Diagnostic test for the qualitative detection of Amphetamine in human urine at cut-off concentration of 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

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