FDA UDI
In Commercial Distribution
🇺🇸 United States
URiSCAN 10 SGL strip
DI: 08806125680217
·
Model: U774
·
YD Diagnostics CORP.
Product Codes
10
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- URiSCAN 10 SGL strip
- Primary DI
- 08806125680217
- Version / Model
- U774
- Company Name
- YD Diagnostics CORP.
- Labeler DUNS
- 687769737
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-21
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 0ed128d8-fb49-47b6-8677-90cfeabef8ff
Device Description
Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitrite, Urobilinogen, Glucose, pH, Blood, SG(Specific Gravity), Ketones(Acetoacetic Acid), Bilirubin and Protein in urine.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quant.) | Clinical Chemistry | 862.1550 | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | 862.1435 | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | Hematology | 864.6550 | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
| 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 |
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
| JRE | Refractometer For Clinical Use | Clinical Chemistry | 862.2800 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806125680217 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K952307 | 000 |