FDA UDI
In Commercial Distribution
🇺🇸 United States
SNT Biotech
DI: 00810057230417
·
Model: SNT-OCAUTO-001
·
SARIS AND THINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SNT Biotech
- Primary DI
- 00810057230417
- Version / Model
- SNT-OCAUTO-001
- Catalog Number
- SNT-OCAUTO
- Company Name
- SARIS AND THINGS, INC.
- Labeler DUNS
- 058264894
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 1
- Public Version Date
- 2024-08-06
- Public Version Status
- New
- Public Device Record Key
- 4a614574-466a-456a-9cb7-41fbd05b3f42
Device Description
STOOL COLLECTION KIT FOR FECAL IMMUNOCHEMICAL TEST (FIT)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54533 | Faecal occult blood IVD, reagent | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810057230417 | GS1 |