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Found 8 results
510(k) Data Aggregation
K Number
K060355Device Name
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-08-07
(175 days)
Product Code
DJC
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.
Device Description
Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL.
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K Number
K060354Device Name
ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-07-28
(165 days)
Product Code
JXM
Regulation Number
862.3170Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual, qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Device Description
Not Found
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K Number
K053037Device Name
ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-06-15
(231 days)
Product Code
DJG
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.
Device Description
A lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine.
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K Number
K053033Device Name
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-06-06
(222 days)
Product Code
DJC
Regulation Number
862.3610Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.
Device Description
Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL.
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K Number
K053034Device Name
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-06-06
(222 days)
Product Code
LDJ
Regulation Number
862.3870Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.
Device Description
Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL
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K Number
K053035Device Name
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-05-05
(190 days)
Product Code
DIO
Regulation Number
862.3250Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug 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) anchiate is preferred.
Device Description
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL
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K Number
K060353Device Name
ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-05-03
(79 days)
Product Code
LCM
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Device Description
Acro Rapid Phencyclidine Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Phencyclidine in human urine at a cutoff of 25 ng/mL.
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K Number
K053032Device Name
ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000
Manufacturer
ACRO BIOTECH LLC.
Date Cleared
2006-02-09
(105 days)
Product Code
DKZ
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
ACRO BIOTECH LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.. The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug 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) analysis is preferred.
Device Description
Acro Rapid Amphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Amphetamine in human urine at a cutoff of 1000 ng/ml.
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