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Device Description : The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay tha The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the dete The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the detection of antibodies to Salmonella (typhoid fever) for the serological confirmation of infections in serum, plasma or heparinized whole blood. This test is intended to be performed by trained laboratory personnel only.
Device Class : 2
Duns Number: 940425333
Premarket Exempt : Yes
Prescription Use : No
Device Description : The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay tha The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay tha The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : 10-fold concentrate of 0.01M PBS
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : 10-fold concentrate of 0.01M PBS
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : Mounting fluid for use with ImmunoFA kits.
Device Class :
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and t The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : Toxoplasma Slides for use with ImmunoFA Toxoplasma kits
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No
Device Description : IgG conjugate for use with ImmunoFA Toxoplasma IgG kit.
Device Class : 2
Duns Number: 940425333
Premarket Exempt : No
Prescription Use : No