DEVICE: Automatic Urine Analyzer (06935740733755)
Device Identifier (DI) Information
Automatic Urine Analyzer
UC-1800
In Commercial Distribution
Urit Medical Electronic Co., Ltd.
UC-1800
In Commercial Distribution
Urit Medical Electronic Co., Ltd.
No description.
Device Characteristics
| MR Safe | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JFY | Enzymatic Method, Creatinine |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| LJX | Test, Urine Leukocyte |
| JIO | Blood, Occult, Colorimetric, In Urine |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| KQO | Automated Urinalysis System |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| JRE | Refractometer For Clinical Use |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K232317 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal |
| Storage Environment Temperature: between -20 and 55 Degrees Celsius |
| Storage Environment Humidity: less than 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e559e632-f6b8-4c62-8ebd-3c97df82f20f
July 23, 2024
2
June 14, 2024
July 23, 2024
2
June 14, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined