FDA.reportPublic FDA data

Epi proColon

Primary DI
04260400670012
Brand
Epi proColon
Company
Epigenomics AG
Model
Sensitive PCR Kit
Catalog number
M5-02-002
Device description
Epi proColon Sensitive PCR Kit
Published
2016-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin DetectionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130001000Epi proColonNew Day Diagnostics, LLC2016-04-12PHP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260400670012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260400670012042604006700124260400670012

GMDN Terms#

Term, Definition table
TermDefinition
Methylated DNA IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of methylated DNA in a clinical specimen. Methylated DNA in specific genes is typically associated with the development of cancer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
340886410
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260400670029Epi proColonControl KitM5-02-0032016-04-25
04260400670036Epi proColonPlasma Quick KitM5-02-0012016-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850057859096Cologuard ® Collection KitEXACT SCIENCES CORPORATIONPHP2026-04-22
00858637005840Analysis Server v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005857Analysis Client v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005864STARlet Interface v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005871Cycler Control v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005888Cologuard Test Definition v1.7EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005901Cologuard 2 Test DefinitionEXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005949The Cologuard Plus Collection KitEXACT SCIENCES CORPORATIONPHP2025-03-19
00850057859003CG2 CAP BDSEXACT SCIENCES CORPORATIONPHP2025-02-19
00850057859010CG2 CAP WSHEXACT SCIENCES CORPORATIONPHP2025-02-19
00850057859027CG2 BND SLNEXACT SCIENCES CORPORATIONPHP2025-02-19
00850057859034CG2 REC BFREXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005918CG2 CNV WSHEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005925CG2 WSHEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005963DNA and LQAS Reagent SLIB Group KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005970DNA Controls SLIB Group KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005987Hemoglobin Bead Based Assay Reagents SLIB Group KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005994Hemoglobin Bead Controls SLIB Goup KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005345CAP SLNEXACT SCIENCES CORPORATIONPHP2024-11-20
00858637005833Reader Control v2.2EXACT SCIENCES CORPORATIONPHP2024-04-25
00858637005338Cologuard STL BFREXACT SCIENCES CORPORATIONPHP2024-01-25
00858637005932Cologuard FILTEXACT SCIENCES CORPORATIONPHP2024-01-25
00858637005420D CTRL 1 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005437D CTRL 2 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005444D CTRL 3 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005451D CAL 1 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005468D CAL 2 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005475D CAL 3 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005482D CAL 4 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005499ENZ KitEXACT SCIENCES CORPORATIONPHP2021-08-27