FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066003404
·
Model: UTI-1S1
·
BTNX Inc
Product Codes
2
GMDN Terms
3
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066003404
- Version / Model
- UTI-1S1
- Catalog Number
- UTI-1S1
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 6
- Public Version Date
- 2023-04-26
- Public Version Status
- Update
- Public Device Record Key
- e9573913-9fb2-4f5e-92d3-9d948c5e9f4e
Device Description
Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitrite and Leukocytes in urine.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | 862.1510 | 1 |
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54521 | Urine nitrite 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 urine for nitrites 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 |
| 54520 | Urine leukocyte 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 urine for leukocytes 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 |
| 65931 | Multiple urine analyte IVD, kit, rapid colorimetric, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This test is intended to be used for self-testing by a layperson in the home or similar environment to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00722066003404 | GS1 | ||||
| Unit of Use | 00722066003718 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063295 | 000 |