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510(k) Data Aggregation
K Number
K964787Device Name
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
Manufacturer
MARDX DIAGNOSTICS, INC.
Date Cleared
1997-04-08
(130 days)
Product Code
LLL
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
MARDX DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MarDx ENA IgG ImmunoStripe Test System is intended for use in testing human serum for the presence of human IgG to extractable nuclear antigens, as an aid in the diagnosis of autoimmune disease, such as systemic lupus erythematosus. Siogren syndrome, scieroderma, and myositis.
Device Description
The MarDx ENA IgG Immunostripe Test System is an enzyme-linked immunosorbent assay (ElA) for the detection of IgG to extractable nuclear antigens in human serum.
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K Number
K951709Device Name
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
Manufacturer
MARDX DIAGNOSTICS, INC.
Date Cleared
1996-06-07
(421 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
MARDX DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MarDx Lyme Disease (IgM) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgM antibody to B. burgdorferi. The MarDx Lyme Disease (IgM) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure.
Device Description
The MarDx Lyme Disease (IgM) Marblot Strip Test System is a Western blot device for the detection of human IgM antibodies directed to the organism Borrelia burgdorferi. The device is similar in function to other solid phase enzyme immunoassays (EIA), but differs in its ability to discriminate the individual antibody specificities directed against the organism.
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K Number
K950829Device Name
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
Manufacturer
MARDX DIAGNOSTICS, INC.
Date Cleared
1996-06-05
(468 days)
Product Code
LSR
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
MARDX DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgG antibody to B. burgdorferi. The MarDx Lyme Disease (1gG) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure.
Device Description
The MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot device for the detection of human IgG antibodies directed to the organism Borrelia burgdorferi. The device is similar in function to other solid phase enzyme immunoassays (EIA), but differs in its ability to discriminate the individual antibody specificities directed against the organism.
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K Number
K960182Device Name
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
Manufacturer
MARDX DIAGNOSTICS, INC.
Date Cleared
1996-03-20
(64 days)
Product Code
LRM
Regulation Number
866.5100Why did this record match?
Applicant Name (Manufacturer) :
MARDX DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The assay is intended for use in detecting antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).
Device Description
The dsDNA Immunoglobulin EIA test system is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of Immunoglobulin to dsDNA in human sera.
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