FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Response
DI: 00722066001219
·
Model: UA-500
·
BTNX Inc
Product Codes
12
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rapid Response
- Primary DI
- 00722066001219
- Version / Model
- UA-500
- Company Name
- BTNX Inc
- Labeler DUNS
- 251005005
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-16
- Public Version
- 2
- Public Version Date
- 2023-04-20
- Public Version Status
- Update
- Public Device Record Key
- 7a893058-0111-4305-a961-599dc8d20814
Device Description
Urine Analyzer 500
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | Clinical Chemistry | 862.1510 | 1 |
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
| JRE | Refractometer For Clinical Use | Clinical Chemistry | 862.2800 | 1 |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Clinical Chemistry | 862.1095 | 1 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Clinical Chemistry | 862.1115 | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | Hematology | 864.6550 | 2 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | 862.1435 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1340 | 2 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1550 | 1 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Clinical Chemistry | 862.1785 | 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 | 00722066001219 | GS1 | ||||
| Direct Marking | 00722066005071 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111221 | 000 |