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510(k) Data Aggregation
K Number
K954923Device Name
BACTEC FUNGAL MEDIUM
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-11-21
(392 days)
Product Code
JTA
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Qualitative culture and recovery of yeasts and fungi from blood
Device Description
BACTEC Fungal Medium is a growth medium providing an aerobic environment for the detection of yeast and fungi. It has been designed for blood volumes of four to 10 mL, and is used specifically with BACTEC non-radiometric (NR) series instruments in the monitoring of clinical blood specimens for the presence of yeasts and fungi. BACTEC Fungal medium has a higher weight/volume concentration of dextrose and sucrose then the predicate device to enhance the recovery and CO2 production of yeast. Saponin was added to the BACTEC Fungal Medium as a lysing agent, and ferric ammonium citrate was added as a source of iron to stimulate recovery of fungi other than yeast. Resin was removed from this medium. Principles for detection of CO2 produced by microorganisms metabolizing blood culture medium nutrients are identical to the predicate device.
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K Number
K954932Device Name
BBL MGIT PRODUCTS
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-08-21
(299 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BBL® MGIT™ Mycobacteria Growth Indicator Tube and BBL® MGIT™ supplemented with BBL® MGIT™ OADC and BBL® MGIT™ supplemented with BBL® MGIT™ PANTA antibiotic mixture, is intended for the detection and recovery of mycobacteria from decontaminated clinical specimens (except urine) and sterile body fluids (except blood). Acceptable clinical specimen types are digested and decontaminated.
Device Description
The BBL® MGIT™ Mycobacteria Growth Indicator Tube contains 4 mL of modified Middlebrook 7H9 Broth Base. The complete medium is supplemented with 0.5 mL OADC enrichment and 0.1 mL of PANTA antibiotic mixture, when necessary. The medium components are substances essential for the growth of mycobacteria. A fluorescent compound is embedded in the bottom of the BBL® MGIT™ tube which is sensitive to the presence of oxygen dissolved in the broth. Specimens are inoculated (0.5 mL) into the BBL® MGIT™ tube and incubated at the appropriate temperature. Tubes are read daily from the second day of inoculation. Actively respiring microorganisms consume the oxygen and allow the compound to fluoresce. Each inoculated BBL® MGIT™ tube is compared to the fluorescence Positive Control and Negative Control tube to assist in the interpretation of a positive signal from the BBL® MGIT™ tube. A BBL® MGIT™ tube which exhibits fluorescence comparable to the Positive Control tube is considered presumptively positive for growth.
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K Number
K962210Device Name
BACTEC 9050 SYSTEM
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-08-08
(59 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.
Device Description
BACTEC® 9050 System is a non-radiometric automated blood culturing system. It has a capacity of 50 specimens, uses Positivity Algorithms by Media Type for culture analysis, has agitation on during testing, uses a Florescence Detector (LED) for detection optics, incubates at 35°C ± 1.5°C, has a protocol length of 4 to 7 Days, uses Florescent Series Media, tests specimens every 10 Minutes, uses Low Voltage DC power supplies, and displays 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.
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K Number
K946268Device Name
BACTEC(R) 9000TB SYSTEM
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-05-21
(515 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Detection of mycobacteria in clinical respiratory specimens
Device Description
BACTEC® 9000MB: 7H9 Middlebrook broth base with nutrient additives, Fluorescence sensor in silicon rubber base, Fluorescent detection of O₂ consumption by mycobacterial growth, On-board incubation at 37°C ± 1.5°C; internal instrument agitation every 10 minutes.
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K Number
K960827Device Name
QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-05-17
(78 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QBC® AUTOREAD™ System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC, platelet count, white blood cell count, granulocyte count (% and number), and lymphocyte/monocyte count (% and number).
Device Description
The QBC® AUTOREAD™ System includes an analyzer, power pack, printer, centrifuge, and test accessories. The system uses specially designed tubes known as the QBC® AccuTube. AccuTubes are filled with blood and centrifuged. The spun tube is placed in the QBC® AUTOREAD™ analyzer which provides a report.
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K Number
K954921Device Name
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-02-16
(113 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954925Device Name
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-02-16
(113 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954927Device Name
BACTEC PEDS PLUS/F CULTURE VIALS
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-02-16
(113 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954930Device Name
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-02-16
(113 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954924Device Name
BACTEC PEDS PLUS CLUTURE VIALS
Manufacturer
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
Date Cleared
1996-02-08
(105 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.
Device Description
BACTEC PEDS PLUS medium is a bacterial growth medium providing an aerobic environment for the detection of bacteria and fungi. It has been designed for the recovery of microorganisms from pediatric and other blood specimens which are generally less than 3 mL in volume and is used specifically with the BACTEC NR ( non-radiometric )blood culture series instruments. Each glass vial of medium contains 20 mL of enriched Soybean-Casein Digest Broth with resins and CO2. If microorganisms are present in the test sample inoculated into the BACTEC vial, CO2 will be produced and liberated into the atmosphere when the organisms metabolize the substrates present in the vial. The instrument analyzes the vial head space gas for CO2 and, If a threshold level is exceeded, indicates that the vial is positive, i.e., that the test sample contains viable organisms.
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