Epi proColon M5-02-001

GUDID 04260400670036

Epi proColon Plasma Quick Kit

Epigenomics AG

Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT) Methylated DNA IVD, kit, nucleic acid technique (NAT)
Primary Device ID04260400670036
NIH Device Record Key6c335c4d-865a-472c-96c3-765a5a8a4b48
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpi proColon
Version Model NumberPlasma Quick Kit
Catalog NumberM5-02-001
Company DUNS340886410
Company NameEpigenomics AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260400670036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-04-25

On-Brand Devices [Epi proColon]

04260400670036Epi proColon Plasma Quick Kit
04260400670029Epi proColon Control Kit
04260400670012Epi proColon Sensitive PCR Kit

Trademark Results [Epi proColon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPI PROCOLON
EPI PROCOLON
85286492 4235996 Live/Registered
Epigenomics AG
2011-04-05

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