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Found 11 results
510(k) Data Aggregation
K Number
K181436Device Name
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Manufacturer
Sekisui Diagnostics, LLC
Date Cleared
2018-06-22
(21 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.
Device Description
The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.
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K Number
K042272Device Name
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
Manufacturer
ACON LABORATORIES, INC.
Date Cleared
2005-02-28
(189 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.
Device Description
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.
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K Number
K030215Device Name
BIORAPID MONONUCLEOSIS
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2003-02-24
(34 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.
Device Description
biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.
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K Number
K012901Device Name
COLOR-MONOGEN
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
2001-09-27
(29 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.
Device Description
Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.
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K Number
K982634Device Name
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
Manufacturer
OXOID, LTD.
Date Cleared
1999-01-28
(184 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM.
Device Description
The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.
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K Number
K981946Device Name
CLEARVIEW IM
Manufacturer
UNIPATH LTD.
Date Cleared
1998-12-10
(190 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.
Device Description
Not Found
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K Number
K972457Device Name
MONOCOL/LEX-IM TEST
Manufacturer
IMMUNOSTICS, INC.
Date Cleared
1997-12-01
(153 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MONOCOL/LEX-IM TEST is a rapid color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of heterophile antibodies in serum or plasma associated with infectious mononucleosis and is to be used as an aid in the diagnosis of infectious mononucleosis. This test is "For Professional Use Only".
Device Description
Not Found
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K Number
K972231Device Name
OSOM MONO TEST 143
Manufacturer
WYNTEK DIAGNOSTICS, INC.
Date Cleared
1997-08-26
(71 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .
Device Description
OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.
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K Number
K963425Device Name
GENZYME DIAGNOSTICS CONTRAST MONO
Manufacturer
GENZYME DIAGNOSTICS
Date Cleared
1997-02-25
(179 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.
Device Description
Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.
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K Number
K961024Device Name
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1997-02-04
(327 days)
Product Code
KTN
Regulation Number
866.5640Why did this record match?
Product Code :
KTN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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