FDA UDI
In Commercial Distribution
🇺🇸 United States
Mission U120 Smart Urine Analyzer
DI: 20682607200492
·
Model: U117-111
·
Acon Laboratories, Inc.
Product Codes
12
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Mission U120 Smart Urine Analyzer
- Primary DI
- 20682607200492
- Version / Model
- U117-111
- Company Name
- Acon Laboratories, Inc.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- 273f97d4-6720-4495-be7d-eed397e876d5
Device Description
URINE ANALYZER with Barcode Reader
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 |
|---|---|---|---|---|
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1785 | 1 |
| JFY | ENZYMATIC METHOD, CREATININE | Clinical Chemistry | 862.1225 | 2 |
| LJX | TEST, URINE LEUKOCYTE | Hematology | 864.7675 | 1 |
| CEN | Dye-indicator, pH (urinary, non-quantitative) | Clinical Chemistry | 862.1550 | 1 |
| JMT | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | Clinical Chemistry | 862.1510 | 1 |
| KQO | AUTOMATED URINALYSIS SYSTEM | Clinical Chemistry | 862.2900 | 1 |
| JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1115 | 1 |
| JIN | NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1435 | 1 |
| JIR | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1645 | 1 |
| JIL | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | Clinical Chemistry | 862.1340 | 2 |
| JRE | REFRACTOMETER FOR CLINICAL USE | Clinical Chemistry | 862.2800 | 1 |
| JIO | BLOOD, OCCULT, COLORIMETRIC, IN URINE | Hematology | 864.6550 | 2 |
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 | 20682607200492 | GS1 |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit