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510(k) Data Aggregation

    K Number
    K063766
    Device Name
    TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2007-04-23

    (124 days)

    Product Code
    DDG, JIT, JJX
    Regulation Number
    866.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples. Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis. For In Vitro Diagnostic Use.
    Device Description
    Good Biotech Corp. Transferrin TIA is a ready to use reagent for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). When transferrin of the serum sample encounters with duck anti-transferrin antibody, the aqqlutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 505 nm is proportional to the transferrin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual transferrin concentration of the serum sample is determined by interpolation of the calibration curve obtained by standard samples with known transferrin concentrations.
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    K Number
    K052617
    Device Name
    FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2006-02-23

    (153 days)

    Product Code
    DBF, JIT, JJX
    Regulation Number
    866.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. (GBC) Ferritin LIT Assay is intended to be used for the quantitative determination of ferritin in human serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism. GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples. GBC ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis. For In Vitro Diagnostic Use. For Prescription Use Only
    Device Description
    Good Biotech Corp. Ferritin LIT Assay is a ready to use reagent for the quantitative determination of ferritin by latex particle enhanced immunoturbidimetry (LIT). Duck anti-ferritin IgY(ΔFc) is coupled to polystyrene microparticles, which greatly increase the analytical sensitivity. When ferritin of the sample encounters with the latex microparticles sensitized with duck anti-ferritin IgY(AFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the ferritin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual ferritin concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known ferritin concentrations.
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    K Number
    K050713
    Device Name
    DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2005-06-06

    (80 days)

    Product Code
    DCN, JIT
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples. For In Vitro Diagnostic Use.
    Device Description
    Duet hs-CRP LIT kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (ΔFc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. When CRP of the sample encounters with the latex microparticles sensitized with duck anti-CRP IgY (ΔFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the CRP concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual CRP concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known CRP concentrations.
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    K Number
    K050576
    Device Name
    MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2005-04-21

    (45 days)

    Product Code
    DDZ, JIT, JJX
    Regulation Number
    866.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease. GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples. GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis. For In Vitro Diagnostic Use.
    Device Description
    Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations.
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    K Number
    K022725
    Device Name
    CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2002-09-23

    (38 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.
    Device Description
    Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay systems within the clinical range.
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    K Number
    K021757
    Device Name
    CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2002-07-29

    (61 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. CRPex-BR C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use. Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples. For In Vitro Diagnostic Use.
    Device Description
    CRPex-BR C-reactive protein LIT Kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity.
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    K Number
    K021882
    Device Name
    CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2002-07-11

    (34 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples. For In Vitro Diagnostic Use.
    Device Description
    The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of CRP in serum samples.
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    K Number
    K020603
    Device Name
    CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
    Manufacturer
    GOOD BIOTECH CORP.
    Date Cleared
    2002-06-13

    (108 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOOD BIOTECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use.
    Device Description
    CRPex-HS C-reactive protein LIT assay is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. CRPex-HS C-reactive protein LIT assay is a hs-CRP assay for CRP quantification in the lower range.
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