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Found 18 results
510(k) Data Aggregation
K Number
K000116Device Name
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
2000-02-15
(32 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992576Device Name
URINE CHEMISTRY CONTROL, LEVEL 1
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1999-09-03
(32 days)
Product Code
JJW
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
Device Description
Urine Chemistry Control, Level 1, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 1 will be offered in 10.0 mL and 25.0 mL fill vials.
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K Number
K992578Device Name
URINE CHEMISTRY CONTROL, LEVEL 2
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1999-09-03
(32 days)
Product Code
JJW
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urine Chemistry Control, Level 2, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
Device Description
Urine Chemistry Control. Level 2, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 2 will be offered in 10.0 mL and 25.0 mL fill vials.
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K Number
K992151Device Name
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1999-07-14
(20 days)
Product Code
LAS
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.
Device Description
Reference Material for Delta-9-THC-COOH in Human Urine
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K Number
K981339Device Name
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1998-04-21
(8 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.
Device Description
QUICKCHECK Lyophilized Chemistry Control Also Distributed as: CONFORMANCE® Chemistry Control C3
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K Number
K974699Device Name
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1998-01-22
(37 days)
Product Code
DKB
Regulation Number
862.3200Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.
Device Description
Reference Material for Amphetamine/Methamphetamine in Human Urine
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K Number
K973469Device Name
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1997-09-25
(21 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clinical laboratories performing chemistry assays may use huve mentioned controls routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls (Levels 1 and 2) are used as an adjunct to primary control procedure recommended by the manufacturer of reagents and instrument used for the measurement; (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory quality control goals; (c ) above mentioned controls are validated for use with the specific clinical chemistry test system used by the laboratory.
Device Description
QUIKCHECK Unassayed Chemistry Control Levels 1 and 2
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K Number
K972146Device Name
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1997-07-08
(29 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided: (a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory; (b.) above mentioned controls are validated for use with the test system being used: (c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.
Device Description
Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls)
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K Number
K972080Device Name
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1997-06-18
(15 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:
(a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems.
(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;
(c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.
These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.
Device Description
Not Found
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K Number
K961815Device Name
QUALITROL ANA CONTROL SERUM SET
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1996-09-27
(140 days)
Product Code
LKJ
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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