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510(k) Data Aggregation
K Number
K991465Device Name
DRUG STOP
Manufacturer
Date Cleared
1999-12-10
(227 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TEXAS IMMUNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.
Device Description
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
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K Number
K980153Device Name
DRUG CHECK
Manufacturer
Date Cleared
1998-03-27
(70 days)
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
TEXAS IMMUNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DRUG CHECK is a rapid immunochromatography assay designed for the simultaneous qualatative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine. It is an in vitro test intended for professional use.
The DRUG CHECK assay provides only a preliminary analytical test result. A more specific alterate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MC) is the preferred confirmatory method. (1) Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Device Description
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K Number
K973208Device Name
FIRST SIGN
Manufacturer
Date Cleared
1997-10-20
(54 days)
Product Code
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
TEXAS IMMUNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Texas FIRST SIGH test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.
Device Description
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K Number
K972094Device Name
TARGET CARDIAC TROPONIN I TEST
Manufacturer
Date Cleared
1997-07-23
(49 days)
Product Code
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
TEXAS IMMUNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A rapid enzyme immunoasay test for the quantitative detection of cardiac troponin-I in serum and heparinized plaama as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.
Device Description
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K Number
K963680Device Name
TARGET MYOGLOBIN TEST
Manufacturer
Date Cleared
1997-02-06
(143 days)
Product Code
Regulation Number
866.5680Why did this record match?
Applicant Name (Manufacturer) :
TEXAS IMMUNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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