FDA.reportPublic FDA data

CG2 WSH

Primary DI
00858637005925
Brand
CG2 WSH
Company
EXACT SCIENCES CORPORATION
Model
100588
Device description
Hb Bead Based Assay Wash, Phosphate Buffer with Detergent (800 mL)
Published
2025-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P230043000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858637005925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858637005925008586370059258586370059250858637005925

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057859096Cologuard ® Collection Kit1009262026-04-22
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
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
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
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