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The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
30397
In Commercial Distribution
- 00857031002103 ()
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
MERIDIAN BIOSCIENCE, INC.
716050
In Commercial Distribution
- 00840733101793 ()
716050
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease.
In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.
MERIDIAN BIOSCIENCE, INC.
712050
In Commercial Distribution
- 00840733101786 ()
712050
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD).
MERIDIAN BIOSCIENCE, INC.
616096
In Commercial Distribution
- 00840733101694 ()
616096
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
MERIDIAN BIOSCIENCE, INC.
611096
In Commercial Distribution
- 00840733101687 ()
611096
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Amplichek I MiniPak (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000531
In Commercial Distribution
- 03610520530092 ()
12000531
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Level 3 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000530
In Commercial Distribution
- 03610520530085 ()
12000530
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Level 2 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000529
In Commercial Distribution
- 03610520530078 ()
12000529
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Level 1 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000528
In Commercial Distribution
- 03610520530061 ()
12000528
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Negative (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000527
In Commercial Distribution
- 03610520530054 ()
12000527
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control