FDA UDI
In Commercial Distribution
🇺🇸 United States
TRI-SLIDE PATIENT ENVELOPE KIT
DI: B224SB191
·
Model: SB-19
·
CENOGENICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- TRI-SLIDE PATIENT ENVELOPE KIT
- Primary DI
- B224SB191
- Version / Model
- SB-19
- Catalog Number
- SB-19
- Company Name
- CENOGENICS CORPORATION
- Labeler DUNS
- 068288943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-27
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 5fa17a9e-6b49-4f7f-ad10-5f3088f87e23
Device Description
Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding. The Kit Contains: 50 patient envelope kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks. The envelopes are printed with easy to understand patient instructions. 3 X 10ml developing solution Product Instructions
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KHE | Reagent, Occult Blood | Hematology | 864.6550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54531 | Faecal occult blood IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B224SB191 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K761232 | 000 |