Search Results
Found 6 results
510(k) Data Aggregation
K Number
K984153Device Name
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1999-01-11
(53 days)
Product Code
LJZ, 83L
Regulation Number
866.3375Why did this record match?
Product Code :
LJZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the manual or automated, qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.
Device Description
Aptus (automated) Application for the Mycoplasma IgM ELISA Test System
Ask a Question
K Number
K971503Device Name
MYCOPLASMA IGM ELISA TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1997-08-20
(118 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Product Code :
LJZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For patients presenting such clinical symptoms, this test system may aid in the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.
Device Description
Zeus Scientific Mycoplasma IgM ELISA Test System.
Ask a Question
K Number
K971393Device Name
MYCOPLASMA IGG ELISA TEST SYSTEM
Manufacturer
IMMUNO PROBE, INC.
Date Cleared
1997-07-14
(96 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Product Code :
LJZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
Device Description
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.
The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Ask a Question
K Number
K970150Device Name
MYCOPLASMA IGG ELISA TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1997-06-16
(152 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Product Code :
LJZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Symptomatic infections attributable to this organism most commonly occur in children and young adults; however, the elderly may also be at risk.
Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever, cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgG-class antibody to M. pneumoniae in human serum. The test system is for in vitro diagnostic use.
Device Description
Not Found
Ask a Question
K Number
K963054Device Name
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
Manufacturer
GenBio
Date Cleared
1997-05-05
(272 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Product Code :
LJZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K963055Device Name
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
Manufacturer
GenBio
Date Cleared
1997-05-02
(269 days)
Product Code
LJZ
Regulation Number
866.3375Why did this record match?
Product Code :
LJZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1