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510(k) Data Aggregation
K Number
K974613Device Name
VIROTROL III
Manufacturer
BLACKHAWK BIOSYSTEMS, INC.
Date Cleared
1998-01-27
(47 days)
Product Code
JJY
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BLACKHAWK BIOSYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.
Device Description
liquid unassayed human serum based quality control material
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K Number
K972129Device Name
CHLAMYDIATROL AG
Manufacturer
BLACKHAWK BIOSYSTEMS, INC.
Date Cleared
1997-08-12
(67 days)
Product Code
MJZ, MGM
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
BLACKHAWK BIOSYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Aq reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.
Device Description
ChlamydiaTrol Ag is a liquid quality control reagent classified under Multi Analyte Controls(assayed and unassayed). ChlamydiaTrol Ag reagent is prepared from Chlamydia trachomatis elementary bodies extracted from infected mouse L cells grown in culture. Optimally infected cells are harvested and disrupted by sonication, and cellular debris is removed by centrifugation. Chlamydia trachomatis elementary bodies used in the preparation of ChlamydiaTrol Ag reagent have been rendered noninfectious by treatment with gamma radiation. The reagent contains human serum albumin(HSA), preservatives and stabilizers.
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