DEVICE: CYBOW 10 (08806141302070)
Device Identifier (DI) Information
CYBOW 10
0004
In Commercial Distribution
DFI CO.,LTD
0004
In Commercial Distribution
DFI CO.,LTD
The one device that has DI number included 100 strips
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 54514 | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JIO | Blood, Occult, Colorimetric, In Urine |
| LJX | Test, Urine Leukocyte |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| JRE | Refractometer For Clinical Use |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
23c28226-47bf-42ae-a273-403e852c9fdd
November 28, 2022
3
June 29, 2020
November 28, 2022
3
June 29, 2020
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