DEVICE: C. DIFF QUIK CHEK (00857031002141)
Device Identifier (DI) Information
C. DIFF QUIK CHEK
30390
In Commercial Distribution
TECHLAB, INC.
30390
In Commercial Distribution
TECHLAB, INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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50832 | Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MCB | Antigen, C. Difficile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K053572 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
f89feb4d-4048-404b-8ccc-672b7d10261d
October 29, 2018
1
September 28, 2018
October 29, 2018
1
September 28, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined