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510(k) Data Aggregation

    K Number
    K082756
    Device Name
    RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2009-10-21

    (397 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raven ProTest - Steam is a self-contained Biological Indicator inoculated with Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.
    Device Description
    The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. ProTest - Steam is intended for use in 10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles.
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    K Number
    K062651
    Device Name
    PROCHEM EXT CHEMICAL INTEGRATOR
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2007-03-15

    (189 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raven ProChem EXT chemical integrator is an integrating chemical indicator intended for monitoring the efficacy of steam sterilization cycles, gravity displacement at 121°C, 20 minutes and prevacuum cycles: 121℃, 20 minutes; 132℃, 8.5 minutes; 134℃, 7.5 minutes and 135℃, 7 minutes.
    Device Description
    ProChem EXT is a 16 mm x 97 mm strip with a 2 mm x 77 mm chemical indicator ink strip printed below a reference triangle exhibiting the endpoint color. The ProChem EXT consists of a paper strip printed with a chemical indicator ink. A chemical reaction occurs changing the ink color from green to black when exposed to the critical parameters of a steam sterilization process.
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    K Number
    K053212
    Device Name
    RAVEN PROPACT
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2006-02-15

    (91 days)

    Product Code
    MRB
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1 <sup>TM</sup> , a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit.
    Device Description
    Not Found
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    K Number
    K050591
    Device Name
    MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2005-03-23

    (15 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raven Bacterial Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of Chemiclave sterilization cycles at 132°C. A reduced incubation time of 72 hours at 60°C +/- 2°C has been validated for Chemiclave sterilization when the Raven Bacterial Spore Strip (either the single species G. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
    Device Description
    Not Found
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    K Number
    K041784
    Device Name
    RAVEN PROTEST - EO
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2004-09-13

    (74 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raven ProTest - EO is a self-contained Biological Indicator inoculated with viable Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization cycles. Raven ProTest - EO has a validated reduced incubation time of 48 hours.
    Device Description
    The biological indicator consists of a self-contained unit that includes bacterial spores of The bloodioal manouler concluded onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromothymol Blue acting as a pH indicator encased in a plastic vial that serves as the culture tube.
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    K Number
    K041386
    Device Name
    RAVEN PROTEST - STEAM
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2004-08-09

    (76 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.
    Device Description
    The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
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    K Number
    K032914
    Device Name
    MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2004-05-25

    (246 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple (single species G. stearothermophilus ATCC #7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced incubation time of 24 hours at 60°C ± 2°C has been validated for steam sterilization when the Spore Strip (either the single species G. stearothermophilus or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
    Device Description
    Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple
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    K Number
    K031114
    Device Name
    PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2004-03-03

    (330 days)

    Product Code
    MRB
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.
    Device Description
    Not Found
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    K Number
    K020026
    Device Name
    RAVEN BACTERIAL SPORE STRIPS
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2002-01-30

    (26 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raven Bacterial Spore Strip (single species B. stearothermophilus ATCC#7953 or dual species B. stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
    Device Description
    Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch.
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    K Number
    K994381
    Device Name
    PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
    Manufacturer
    RAVEN BIOLOGICAL LABORATORIES, INC.
    Date Cleared
    2001-03-30

    (458 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN BIOLOGICAL LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProSpore2 is a biological sterilization process indicator for EtO (Ethylene Oxide) sterilization. This device is intended for use by a health care provider to accompany products being sterilized through an EtO sterilization procedure and to monitor the adequacy of sterilization. The testing and validations referred to in this document were done using a 10/90 Ethylene Oxide mixture at 600 mg/L, 54°C, and with a relative humidity between 30% and 80%.
    Device Description
    ProSpore2 is a self-contained biological indicator used for determining the efficacy of an Ethylene Oxide sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1.2 - 1.5 ml glass ampoule of growth media consisting of Tryptic Soy Broth (soybean casein digest) and a pH indicator - bromothymol blue. Also inside of the tube housing is a paper spore disc impregnated with a population of 106 Bacillus subtilis spores (ATCC #9372).
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