ColoSense Collection Kit

Primary DI
00860009064317
Brand
ColoSense Collection Kit
Company
Geneoscopy, Inc.
Model
1
Device description
Device is a stool collection kit for at-home use.
Published
2025-09-25
Public version status
New
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
SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin DetectionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230001005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230001005ColoSense®Geneoscopy, Inc.2024-05-03SBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009064317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009064317008600090643178600090643170860009064317

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079747685
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
00198715728941ColoSense Collection Kit02024-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715728941ColoSense Collection KitGeneoscopy, Inc.SBB2024-07-30