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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 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.
30392B
In Commercial Distribution

  • 00857031002448 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
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.
30397B
In Commercial Distribution

  • 00857031002431 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
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.
T5015B
In Commercial Distribution

  • 00857031002424 ()


  • 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.
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 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)
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)
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.
30394
In Commercial Distribution

  • 00857031002042 ()


  • 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)
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)
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)
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)
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)
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)
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.
T30525C
In Commercial Distribution

  • 00857031002059 ()


  • 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
VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
BIOMERIEUX SA
30125-01
In Commercial Distribution

  • 03573026444204 ()


  • Clostridium difficile antigen IVD, antibody
The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
BIOMERIEUX SA
30118-01
In Commercial Distribution

  • 03573026229146 ()


  • 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
No Description
DIAGNOSTICA STAGO
00943
In Commercial Distribution

  • 03607450009439 ()


  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)
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