DEVICE: Exact Diagnostics (00812242030734)
Device Identifier (DI) Information
Exact Diagnostics
CDFP200
In Commercial Distribution
CDFP200
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution
CDFP200
EXACT DIAGNOSTICS, LLC
C. difficile Verification Panel
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
50838 | Clostridium difficile nucleic acid IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OHQ | Multi-Analyte Controls Unassayed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than -20 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
49868054-304c-4c3f-89d0-3a7e313e1fba
September 27, 2019
1
September 19, 2019
September 27, 2019
1
September 19, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8179899262
customerservice@exactdiagnostics.com
customerservice@exactdiagnostics.com