Address:3471 River Hills Dr,CINCINNATI,OH,45244,US
Device Description : The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histoplasma capsulatum antigen reagents are standardized, purified preparations Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Coccidioides immitis antigen reagents are standardized, purified preparations fo Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Coccidioides immitis antigen reagents are standardized, purified preparations fo Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histoplasma capsulatum antigen reagents are standardized, purified preparations Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Coccidioides immitis antigen reagents are standardized, purified preparations fo Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Coccidioides immitis antigen reagents are standardized, purified preparations fo Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen CALAS Pronase is a serum pretreatment reagent for use with Cryptococcal Antigen Latex Agglutination System (CALAS).
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and The Cryptococcal Antigen Latex Agglutination System (CALAS) is a qualitative and semiquantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneu MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes