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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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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)
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)
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)
No Description
Roche Molecular Systems, Inc.
09040773190
In Commercial Distribution

  • 00875197006476 ()
09040773190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Diagnostics GmbH
06999069190
In Commercial Distribution

  • 00875197004847 ()
06999069190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Diagnostics GmbH
1.0
In Commercial Distribution

  • 00875197004748 ()
06998887190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
2.0
In Commercial Distribution

  • 00875197004014 ()
05965390190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
05002125190
In Commercial Distribution

  • 00875197002676 ()
05002125190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
04626303190
In Commercial Distribution

  • 00875197001754 ()
04626303190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
03302555018
In Commercial Distribution

  • 00875197001051 ()
03302555018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
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