DEVICE: Epi proColon (04260400670012)
Device Identifier (DI) Information
Epi proColon
Sensitive PCR Kit
In Commercial Distribution
M5-02-002
Epigenomics AG
Sensitive PCR Kit
In Commercial Distribution
M5-02-002
Epigenomics AG
Epi proColon Sensitive PCR Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
59010 | Methylated DNA IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials (e.g., software) intended to be used for the qualitative and/or quantitative detection of methylated DNA in a clinical specimen. Methylated DNA and DNA methylation patterns in specific genes or genomic regions are typically associated with the development of cancer.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P130001 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -25 and -15 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e27d46e8-2ec9-4c0c-a42c-484e0f6177a3
May 24, 2021
5
April 25, 2016
May 24, 2021
5
April 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined