ColoSense Collection Kit
- Primary DI
- 00198715728941
- Brand
- ColoSense Collection Kit
- Company
- Geneoscopy, Inc.
- Model
- 0
- Device description
- Device is a stool collection kit for at-home use.
- Published
- 2024-07-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| SBB | System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| SBB | System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P230001 | 000 | ColoSense® | Geneoscopy, Inc. | 2024-05-03 | SBB |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00198715728941 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00198715728941 | 00198715728941 | 198715728941 | 0198715728941 |
GMDN Terms
| Term | Definition |
|---|
| Faecal specimen collection kit IVD, home-use | A 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 | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 079747685
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860009064317 | ColoSense Collection Kit | 1 | | 2025-09-25 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00860009064317 | ColoSense Collection Kit | Geneoscopy, Inc. | SBB | 2025-09-25 |