FDA UDI
In Commercial Distribution
🇺🇸 United States
Uri-Trak 120 M Urine Analyzer
DI: 00657498002094
·
Model: G1300-001
·
STANBIO LABORATORY, L.P.
Product Codes
12
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Uri-Trak 120 M Urine Analyzer
- Primary DI
- 00657498002094
- Version / Model
- G1300-001
- Catalog Number
- G1300-001
- Company Name
- STANBIO LABORATORY, L.P.
- Labeler DUNS
- 045361136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- 8f057c17-c18a-4bf1-a883-ca7ac1c6ba9e
Device Description
The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. 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.
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 |
|---|---|---|---|---|
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
| KQO | Automated Urinalysis System | Clinical Chemistry | 862.2900 | 1 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Clinical Chemistry | 862.1785 | 1 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1550 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1340 | 2 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | 862.1435 | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | Hematology | 864.6550 | 2 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Clinical Chemistry | 862.1115 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | 862.1510 | 1 |
| JRE | Refractometer For Clinical Use | Clinical Chemistry | 862.2800 | 1 |
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Clinical Chemistry | 862.1095 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35918 | Urine analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used 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 | 00657498002094 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]