FDA UDI
In Commercial Distribution
🇺🇸 United States
Red Tunica
DI: 00850036464662
·
Model: RT-20132
·
Rodimedi & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Red Tunica
- Primary DI
- 00850036464662
- Version / Model
- RT-20132
- Catalog Number
- RT-20132
- Company Name
- Rodimedi & Associates, Inc.
- Labeler DUNS
- 785417726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-03-14
- Public Version
- 1
- Public Version Date
- 2025-03-24
- Public Version Status
- New
- Public Device Record Key
- c1890073-4111-458a-98ba-5ffbf4e1e230
Device Description
The RedTunica™ One Step iFOB is a rapid immunoassay for the qualitative detection of human occult blood in human fecal specimens.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 54532 | Faecal occult blood IVD, kit, rapid ICT, 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 and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 20850036464666 | GS1 | ||||
| Primary | 00850036464662 | GS1 |
Customer Contacts
- Phone
- 18883159472
- [email protected]