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Microsoft word - reszon pi - doa single 2012-02

Product insert for testing any of the following drugs: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Erimin, Ketamine, Marijuana, Methamphetamine, & Morphine. INTENDED USE
WARNINGS AND PRECAUTIONS
FastScreen™ Single Drug Test is a rapid, competitive binding
1. For professional in vitro diagnostic use only. immunoassay for qualitative determination of different drugs and drug 2. Do not use kit beyond the expiration date. metabolites in human urine. It is intended for professional and laboratory 3. The test device should remain in the sealed pouch until use. use only. The assay should not be used without proper supervision and is 4. Urine specimens may be infectious, properly handle and dispose of not intended for over the counter sale to layperson. all used reaction devices into a biohazard container. The test provides only preliminary data which should be confirmed by other analytical methods, such as gas chromatography/ mass
spectrophotometry (GC/MS). The preliminary positive results should be
Store the test kits at 4-30°C, do not freeze. Refer to the expiration date for justified with compelling clinical consideration and professional SAMPLE COLLECTION AND PREPARATION
SUMMARY AND EXPLANATION OF THE TEST
The urine specimen must be collected into a clean and dry container. FastScreen™ Single Drug Test is an easy, fast, and visually read
Urine can be collected at any time of the day. Urine specimens exhibiting screening method without the use of any instrument. The test system visible precipitates should be allowed to settle to obtain a clear specimen employs unique polyclonal antibodies to selectively identify specific drugs and drug metabolites in urine samples with a high degree of sensitivity. Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored Ketamine, Marijuana, Methamphetamine, and Morphine are of clinical below -20°C. Frozen specimens should be thawed and mixed well before importance to treat patients in various circumstances.1,4,6 These drugs and their metabolites can be detected in urine as a result of drug abuse. Immunoassay testing has been developed for the determination of their concentration in urine at various cut-off values.7-10 These values are in ASSAY PROCEDURE
accordance with the United States Substance Abuse and Mental Health Bring the urine sample and the test components to room Services Administration (SAMHSA).11 These drugs’ respective use in clinical applications and their corresponding cut-off values can be referred Once ready, tear open the foil pouch at the notch and remove the in separate evaluation sheets. Please contact the manufacturer for With arrows pointing towards the urine sample, immerse the test dipstick into the urine sample for at least 6-10 seconds. When immersing, make sure that the urine sample do not exceed the PRINCIPLE
maximum-level line indicated. See the illustration below. The FastScreen™ Single Drug Test is a chromatographic absorbent
Lay the test dipstick flatly on a non-absorptive clean surface. device in which drug or drug metabolites in a sample compete with drug Read the test result within five minutes. conjugate immobilized on a porous membrane support for limited * IMPORTANT: The result must be interpreted within five (5)
minutes. Waiting more than five (5) minutes may cause the reading Labeled antibody-dye conjugate mixes with sample specimen and binds to be inaccurate. To avoid confusion, discard the test device after to the free drug or drug metabolites present to form an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the test zone preventing the formation of a purplish-pink color band when the drug is above the detection level. Unbound dye conjugate binds to the reagent in the control zone and produces a purplish-pink color band, demonstrating that the reagents and device are functioning correctly. A negative specimen produces two distinct color bands, one in the test zone and one in the control zone. A positive specimen produces only one INTERPRETATION OF RESULTS
Negative: Two horizontal purplish-pink color bands appear, one in
REAGENTS AND MATERIALS SUPPLIED
the control zone and one in the test zone. The color intensity of the 1. 100 pieces of FastScreen™ Single Drug Test dipsticks: Each test
control line and test line may not be equal. Any faint band appears at dipstick contains membrane-immobilized reagent specific to the drug the test zone, visible within 5 minutes, should be interpreted as presence of the test line. This is a negative result and indicates that 2. 1 copy of Product insert
the drug concentration is below the detection sensitivity. Positive: A purplish-pink color band appears in the control zone but
not in the test zone. This is a positive result and indicates that the MATERIALS REQUIRED, BUT NOT PROVIDED
drug level is at or above the detection sensitivity. 1. Urine container for sample collection and testing It is recommended that all positive results to be confirmed by using Invalid: If no band appears, or a test band appears without a control
band, disregard the results and repeat with a new test. The presence of a control line is necessary to validate test performance. QUALITY CONTROL
An internal procedural control has been incorporated into the test to Precision. The precision was determined by replicate assays of
ensure proper kit performance and reliability. A colored line appearing in three different patient urine samples with kits from three different the control line region (C) confirms that sufficient specimen volume, adequate membrane wicking and correct procedural technique. production lots. The resultant data indicated 100% precision for the duplicates within each lot and no appreciable inter-lot variation Control standards are not supplied with this kit. However, it is when testing both positive and negative spiked samples across recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test BIBLIOGRAPHY
Huang, W., Andolto, W., Hearn W.L. J. Anal. Toxicol., 16:307-310 LIMITATIONS OF THE TEST
This product is designed for use with human urine only. Cody, J.T., and Schwarzhoff, R.J. Anal. Toxicol., 17: 2630 (1993). Although the test is accurate, there is possibility that false results Glare, P.A., and Pippenger, C.E., Ther. Drug Monit., 13:226-232 occur due to the presence of interfering substances in the urine Walsh, T.D., Cheater, F.M., Pharm. J., 10:525-527 (1983). The test is a qualitative screening assay and is not for determining Mitchell, J.M, Paul, B.D., Welch, P, Cone, E. J. Anal. Toxicol., quantitative concentration levels or the level of intoxication. Adulterants such as bleach or other strong oxidizing agents, when Department of Health and Human Services, Fed. Regist., 53(69): added to urine specimens may produce erroneous test results regardless of the analysis method used. If adulteration is suspected, Cone, E.J., Dickerson, S., Paul, B.D., Mitchell, J.M., J. Anal. obtain another urine specimen and retest. Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd PERFORMANCE CHARACTERISTICS
Ed., Biomedical Publ., Davis, CA, p. 488 (1982). Sensitivity. The FastScreen™ Single Drug Test detects the
Urine Testing for Drugs of Abuse, NDA Research Monograph, 73, specified drug and its metabolites in urine at concentrations equal to or greater than the specific cut-off values: 10. FDA Guidance for Labeling Urine Drugs of Abuse Screening Drug Test
Cut-off ((ng/ml)
11. SAMHSA. Mandatory Guidelines and Proposed Revisions to Mandatory Guidelines for Federal Workplace Drug Testing ORDERING INFORMATION
DT-RD01-AMP
DT-RD01-BAR
DT-RD01-BZO
Specificity. A study was conducted with the FastScreen™ Single
Drug Test to determine the cross-reactivity of non-related
DT-RD01-COC
compounds with the test at concentrations much higher than normally found in the urine of people using or abusing them. No DT-RD01-ER5
cross-reactivity was detected with the substances listed in Table 1. DT-RD01-KET
Note: For a more comprehensive list for the cross-reactivity study
for each type of drugs, please refer to separate sheets that can be
obtained from the manufacturer.

DT-RD01-THC
Table 1: Compounds tested and found not to cross-react with the test at
DT-RD01-MET
DT-RD01-MOP
DISTRIBUTED BY:
17B, Jalan Kota Raja F 27/F, Hicom Town Centre, Seksyen 27, MANUFACTURED BY:
Reszon Diagnostics International Sdn. Bhd. Revongen Corporation Center, No.12A, Jalan TP5, Taman Perindustrian UEP, 47600 Subang Jaya, Selangor, Malaysia Accuracy. Evaluation from the Doping Control Centre (DCC) is
currently conducted. Please contact the manufacturer for full

Source: http://www.reszonics.com/Reszon%20PI%20-%20DOA%20Single.pdf

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