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Found 13 results
510(k) Data Aggregation
K Number
K001215Device Name
DBEST HCG 2 IU/ML TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
2000-06-22
(69 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990873Device Name
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
Manufacturer
AMERITEK, INC.
Date Cleared
1999-09-01
(169 days)
Product Code
JMT, JIR
Regulation Number
862.1510Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.
Device Description
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine.
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K Number
K990681Device Name
DBSET MULTIDRUG SCREEN TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1999-07-15
(135 days)
Product Code
DKZ, DIO, DJG, LAF, LDJ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest MultiDrug Screen Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml, cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml, methamphetamines and its metabolites such as oxidized, deaminated derivatives in urine with cutoff of 1000 ng/ml, opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml and tetrahydrocannabinol and its metabolites 11-nor- 9tetrahydrocannabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest MultiDrug Screen Test Kits are for professional and laboratory use only.
Device Description
Not Found
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K Number
K984269Device Name
DBEST OCCULT BLOOD TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1999-05-11
(201 days)
Product Code
KHE
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory use only.
Device Description
Not Found
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K Number
K983188Device Name
DBEST TETRAHYDROCANNABINOL TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1998-11-18
(68 days)
Product Code
LDJ
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only.
Device Description
dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml.
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K Number
K983189Device Name
DBEST METHAMPHETAMINES TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1998-11-18
(68 days)
Product Code
LAF
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, deaminated and conjugated derivatives in urine. dBest Methamphetamines Test Kit is intended for professional and laboratory use only.
Device Description
dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, deaminated and conjugated derivatives in urine.
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K Number
K983190Device Name
DBEST OPIATES TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1998-11-18
(68 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml. The dBest Opiates Test Kits are for professional and laboratory use only.
Device Description
dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml.
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K Number
K983191Device Name
DBEST COCAINE TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1998-11-18
(68 days)
Product Code
DIO
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml. The dBest Cocaine Test Kits are for professional and laboratory use only.
Device Description
dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml.
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K Number
K981504Device Name
DBEST AMPHETAMINES TEST KIT
Manufacturer
AMERITEK, INC.
Date Cleared
1998-08-06
(101 days)
Product Code
DKZ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.
Device Description
Not Found
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K Number
K974508Device Name
DBEST ONE-STEP OVULATION TEST
Manufacturer
AMERITEK, INC.
Date Cleared
1998-02-02
(63 days)
Product Code
CEP
Regulation Number
862.1485Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest Ovulation Test measures luteinizing hormone (LH), which is always present in women's urine, and increases just before most fertile day of the month. This increase, or "surge" in LH triggers ovulation, which is the release of an egg from ovary. dBest Ovulation Test will help women find the time that when they are most able to become pregnant. Fir accounter USC.
Device Description
dBest Ovulation luteinizing hormone (LH).
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