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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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C. DIFF QUIK CHEK COMPLETE - 00857031002387

The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
30550C
In Commercial Distribution

  • 00857031002387 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK COMPLETE - 00857031002370

The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
30525C
In Commercial Distribution

  • 00857031002370 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

TOX A/B QUIK CHEK - 00857031002257

The TOX A/B QUIK CHEK® test is a rapid immunoassay for detecting Clostridium difficile 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.
T5033
In Commercial Distribution

  • 00857031002257 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF CHEK - 60 - 00857031002233

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.
TECHLAB, INC.
T5025B
In Commercial Distribution

  • 00857031002233 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF CHEK - 60 - 00857031002226

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.
TECHLAB, INC.
T5025
Not in Commercial Distribution

  • 00857031002226 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFFICILE TOX A/B II - 00857031002219

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.
T5015
In Commercial Distribution

  • 00857031002219 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK COMPLETE - 00857031002158

The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting 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. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30550C
In Commercial Distribution

  • 00857031002158 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF QUIK CHEK - 00857031002141

The C. DIFF QUIK CHEK test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
30390
In Commercial Distribution

  • 00857031002141 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFF CHEK - 60 - 00857031002110

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.
TECHLAB, INC.
30392
In Commercial Distribution

  • 00857031002110 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

C. DIFFICILE TOX A/B II - 00857031002103

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)
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