FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 10722066004408
·
Model: UA-U120S
·
BTNX Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 10722066004408
- Version / Model
- UA-U120S
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-30
- Public Version
- 1
- Public Version Date
- 2023-11-07
- Public Version Status
- New
- Public Device Record Key
- e5c5a071-5ae2-4af5-9160-35ee115b79ca
Device Description
The Rapid Response® U120S Urine Analyzer is intended for use in conjunction with the Rapid Response® Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human urine. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. The instrument is intended for professional, in vitro diagnostic use only.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQO | Automated Urinalysis System | Clinical Chemistry | 862.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57861 | Urine analyser IVD, point-of-care | A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10722066004408 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120124 | 000 |