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510(k) Data Aggregation

    K Number
    K120652
    Device Name
    RAPICIDE OPA-28 TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2012-10-12

    (224 days)

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

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.
    Device Description
    The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad that has been chemically treated to detect OPA. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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    K Number
    K092346
    Device Name
    SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2010-01-07

    (156 days)

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

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.
    Device Description
    The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square indicator pad that has been chemically treated to detect GTA. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
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    K Number
    K083295
    Device Name
    SERIM DISINTEK GTA 2.1%, MODEL: 5164
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2009-03-16

    (126 days)

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

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.
    Device Description
    The device is a qualitative, single use, reagent test strip made up of a 0.40-inch square reagent pad that has been chemically treated to detect glutaraldehyde in CIDEXPLUS 28 Day solutions. The pad is affixed to one end of a 3.25 inch by 0.40-inch white opaque polystyrene strip.
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    K Number
    K082352
    Device Name
    SERIM DISINTEK OPA TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2008-09-25

    (40 days)

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

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Metricidc OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.
    Device Description
    The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Metricide OPA Plus Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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    K Number
    K081370
    Device Name
    SERIM DISINTEK OPA TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2008-07-11

    (57 days)

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

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.
    Device Description
    The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Cidex OPA Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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    K Number
    K080712
    Device Name
    SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2008-05-06

    (54 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
    Device Description
    The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
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    K Number
    K052388
    Device Name
    SERIM PERACETIC ACID CHEMICAL INDICATOR
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2005-12-01

    (92 days)

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

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim ® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.
    Device Description
    The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square purple reagent pad that has been chemically treated to detect the active ingredient in the Steris 20™ Sterilant® when used in the STERIS SYSTEM 1® Processor™. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The Serim* Peracetic Acid Chemical Indicator is configured as a paper pad on a plastic strip support. A dve in the chemical indicator pad is oxidized (bleached) by the use solution. The extent of bleaching indicates whether a sufficient concentration active agent (peracetic acid) was present. At the end of the processing evele the user compares the reacted indicator to a color chart composed of two color blocks. The "START" color block is similar to the unreacted indicator strip. The =COMPLETE color block is similar to an indicator strip that has been exposed to peracetic acid at or above a concentration of 1500 ppm.
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    K Number
    K043031
    Device Name
    SERIM DIALYSATE MONITOR TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2005-06-13

    (222 days)

    Product Code
    NTZ
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim™ Dialysate Monitor™ Test Strip provides semi-quantitative indications of pH, bicarbonate, and glucose (which acts as a tracer for the acid concentrate) concentrations in final bicarbonate dialysate solutions. They can be used to monitor the proper preparation of such dialysate solutions. The Serim™ Dialysate Monitor™ Test Strips are to be used to supplement current methods for testing dialysate.
    Device Description
    SERIM Dialysate Monitor Test Strips are firm plastic strips that contain three reagent areas to test for pH, bicarbonate/carbonate ion, and glucose in dialysate. The glucose concentration is a tracer of the amount of acid concentrate added to the dialysate.
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    K Number
    K014038
    Device Name
    PYLORITEK VP TEST KIT 5140VP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2002-02-08

    (63 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PyloriTek VP Test Kit includes materials for detection of urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. The test is for use on symptomatic patients by healthcare professionals.
    Device Description
    Helicobacter pylori grows on the gastric mucosa and colonies can be collected with biopsies taken during gastrointestinal endoscopy. H. pylori produces urease which is a useful marker for gastric infections. Pyloritek VP Test Kit detects urease activity in gastric biopsy specimens. Serim PyloriTek VP Test Kit has the following components: Reagent strips which contain, in separate dry reagent matrices, the substrate urea (Substrate Pad) and a pH indicator (Reaction Pad). The Reaction Pad containing the pH indicator is covered by a semi-permeable membrane which allows passage of gaseous ammonia but prevents passage of gastric tissue fluid or Hydration Reagent from the Substrate Pad. Hydration Reagent which contains a buffer that is dispensed on the Substrate Pad prior to performing the test. Reaction Chamber which is a plastic device that holds developing strips and provides solid contact between the gastric biopsy, the Substrate Pad and the Indicator Pad. This arrangement ensures that ammonia gas generated is directed through the semi-permeable membrane to the pH indicator. PyloriTek VP Positive Control Paper is provided separately to be used as a quality control material with the PyloriTek VP Test Kit. This control is a 0.2 x 3.25 inch strip of paper containing dry urease, buffer and stabilizer. PyloriTek VP Positive Control is run on PyloriTek VP Test Strips separate from biopsy specimens.
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    K Number
    K012115
    Device Name
    SERIM BLOOD LEAK TEST STRIP-2
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2001-11-30

    (147 days)

    Product Code
    FJD
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERIM RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Serim Blood Leak Test Strips – 2 provide a rapid and convenient means for testing dialysate for occult blood leaks that may occur during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.
    Device Description
    The SERIM Blood Leak Test Strips-2 consist of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.
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