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Found 5 results
510(k) Data Aggregation
K Number
K992939Device Name
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
Manufacturer
SERACARE TECHNOLOGY
Date Cleared
1999-12-09
(100 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
SERACARE TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized QUAEFFROE immONessayed quality control material intended to monitor the naman ocrain bacoa a immunoassay test procedures that analyze performanoo of climos. Intreaputic drugs as listed in this package insert.
Device Description
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized QUAEFFROE immONessayed quality control material
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K Number
K993631Device Name
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
Manufacturer
SERACARE TECHNOLOGY
Date Cleared
1999-12-09
(43 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
SERACARE TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material intended to monitor the naman of clinical immunological test procedures that analyze for tumor associated antigens.
Device Description
QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material.
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K Number
K993715Device Name
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
Manufacturer
SERACARE TECHNOLOGY
Date Cleared
1999-11-16
(13 days)
Product Code
JJT
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
SERACARE TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.
Device Description
liquid human serum based assayed quality control material
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K Number
K992770Device Name
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
Manufacturer
SERACARE TECHNOLOGY
Date Cleared
1999-11-12
(87 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
SERACARE TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.
Device Description
Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.
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K Number
K992395Device Name
URINE DRUG SCREENING CONTROL
Manufacturer
SERACARE TECHNOLOGY
Date Cleared
1999-08-26
(38 days)
Product Code
DIF
Regulation Number
862.3280Why did this record match?
Applicant Name (Manufacturer) :
SERACARE TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor the performance of screening, semiquantitative and confirmatory drug-of-abuse testing procedures.
Device Description
Urine Drug Screening Control is designed to monitor the performance of screening, semi-quantitative and confirmatory drugs-of-abuse testing procedures. Purified drugs or drug metabolites added to a human urine based matrix to provide a stable liquid control, which closely mimics drug containing human urine. The product contains <0.1% sodium azide as a preservative.
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