FDA.reportPublic FDA data

Cologuard ® Collection Kit

Primary DI
00850057859096
Brand
Cologuard ® Collection Kit
Company
EXACT SCIENCES CORPORATION
Model
100926
Device description
Sample collection kit for Cologuard and Cologuard Plus.
Published
2026-04-22
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
P130017000
P230043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130017000COLOGUARDExact Sciences Corporation2014-08-11PHP
P230043000Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™Exact Sciences Corporation2024-10-03PHP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057859096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057859096008500578590968500578590960850057859096

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Regulatory Flags#

DUNS number
150908853
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858637005895Cologuard Capture Aspirator3004902022-12-08
00858637005840Analysis Server v2.22.22025-03-19
00858637005857Analysis Client v2.22.22025-03-19
00858637005864STARlet Interface v2.22.22025-03-19
00858637005871Cycler Control v2.22.22025-03-19
00858637005888Cologuard Test Definition v1.71.72025-03-19
00858637005901Cologuard 2 Test Definition1.12025-03-19
00858637005949The Cologuard Plus Collection Kit1006762025-03-19
00850057859003CG2 CAP BDS1006992025-02-19
00850057859010CG2 CAP WSH1005182025-02-19
00850057859027CG2 BND SLN1007002025-02-19
00850057859034CG2 REC BFR1005422025-02-19
00858637005918CG2 CNV WSH1005432025-02-19
00858637005925CG2 WSH1005882025-02-19
00858637005963DNA and LQAS Reagent SLIB Group Kit1007292025-02-19
00858637005970DNA Controls SLIB Group Kit1007282025-02-19
00858637005987Hemoglobin Bead Based Assay Reagents SLIB Group Kit1007272025-02-19
00858637005994Hemoglobin Bead Controls SLIB Goup Kit1007302025-02-19
00858637005345CAP SLN1002512024-11-20
00858637005833Reader Control v2.22.22024-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00858637005505MIX A KitEXACT SCIENCES CORPORATIONPHP2021-08-27