Genbio

Address:15222 AVE. OF SCIENCE,Rancho Bernardo,CA,92128,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (4) Reagent, Borrelia Serological Reagent (LSR) (3) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) Immunochemical, Thyroglobulin Autoantibody (JNL) (1) System, Test, Anticardiolipin Immunological (MID) (1)

Premarket Exempt

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ImmunoWELL Cardiolipin (IgM) Test - 00613745031002 Catalog Number : 3100

Device Description : The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

ImmunoWELL Borrelia (Lyme) - 00613745031101 Catalog Number : 3110

Device Description : The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the quali The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the qualitative and/or semi-quantitative detection of Borrelia burgdorferi total antibodies (IgG, IgM, and IgA) in serum and is used as an aid in the diagnosis of Lyme disease.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

ImmunoDOT Borrelia Positive Control - 00613745039053 Catalog Number : 3905

Device Description : This serum control contains IgG antibodies specific to Borrelia burgdorferi, the This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

ImmunoDOT Thyroid Positive Control - 00613745039121 Catalog Number : 3912

Device Description : Thyroid Positive Control contains antibodies specific to human thyroid peroxidas Thyroid Positive Control contains antibodies specific to human thyroid peroxidase (TPO, microsome) and human thyroglobulin. This control is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

ImmunoDOT Serum Control D - 00613745039183 Catalog Number : 3918

Device Description : Substitute Serum Control D for specimen. Otherwise follow the Procedure as descr Substitute Serum Control D for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Autoimmunity Test package insert.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

ImmunoDOT Negative Control - 00613745039206 Catalog Number : 3920

Device Description : Substitute Negative Control for specimen. Otherwise follow the Procedure as desc Substitute Negative Control for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Test package insert.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

ImmunoDOT Borrelia Test - 00613745050256 Catalog Number : 5025

Device Description : The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

ImmunoDOT Autoimmunity Panel 1 - 00613745051253 Catalog Number : 5125

Device Description : The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

ImmunoDOT Autoimmunity Panel 1 - 00613745051895 Catalog Number : 5189

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LJM

Prescription Use : No

Device Count : 1

ImmunoDOT Autoimmunity Panel 4 - 00613745054254 Catalog Number : 5425

Device Description : The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

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