Primary Device ID | 04260400670029 |
NIH Device Record Key | e6efb29c-9a51-49e0-9b99-37a5bac8b198 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Epi proColon |
Version Model Number | Control Kit |
Catalog Number | M5-02-003 |
Company DUNS | 340886410 |
Company Name | Epigenomics AG |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04260400670029 [Primary] |
PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-12-11 |
Device Publish Date | 2016-04-25 |
04260400670036 | Epi proColon Plasma Quick Kit |
04260400670029 | Epi proColon Control Kit |
04260400670012 | Epi proColon Sensitive PCR Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EPI PROCOLON 85286492 4235996 Live/Registered |
Epigenomics AG 2011-04-05 |