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Device Description : The ZEUS IFA Autoantibody Screen (AAS) Rat Kidney/Stomach Tissue Test System is The ZEUS IFA Autoantibody Screen (AAS) Rat Kidney/Stomach Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, smooth muscle and parietal cell antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Autoantibody Screen (AAS) Rat Kidney/Stomach/Liver Tissue Test Syst The ZEUS IFA Autoantibody Screen (AAS) Rat Kidney/Stomach/Liver Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, smooth muscle and parietal cell antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Autoantibody Screen (AAS) Mouse Kidney/Stomach/Liver Tissue Test Sy The ZEUS IFA Autoantibody Screen (AAS) Mouse Kidney/Stomach/Liver Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, smooth muscle and parietal cell antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Anti-Smooth Muscle Antibody (ASMA) Test System is designed for the The ZEUS IFA Anti-Smooth Muscle Antibody (ASMA) Test System is designed for the qualitative and semi-quantitative detection of Smooth Muscle Antibodies (SMA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Anti-Thyroid Antibody (ATA) Test System is designed for the qualita The ZEUS IFA Anti-Thyroid Antibody (ATA) Test System is designed for the qualitative and semi-quantitative detection of Thyroid Antibodies (TA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Anti-Skin Antibody (ASA) Test System is designed for the qualitativ The ZEUS IFA Anti-Skin Antibody (ASA) Test System is designed for the qualitative and semi-quantitative detection of antibodies associated with Pemphigus and Bullous Pemphigoid by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is The ZEUS IFA Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS The ZEUS IFA Fluorescent Treponemal Antibody-Absorption Double Stain (FTA-ABS DS) Test System is designed to confirm positive non-treponemal reagin tests for syphilis and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is The ZEUS IFA Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ZEUS IFA Toxoplasma gondii IgG Test System is designed to detect the presenc The ZEUS IFA Toxoplasma gondii IgG Test System is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Device Class :
Duns Number: 080953946
Premarket Exempt : No
Prescription Use : Yes