FDA UDI
In Commercial Distribution
🇺🇸 United States
urinalysis strips
DI: 06971257037177
·
Model: 3T
·
Weihai Kangzheng Medical Equipment Technology Co., Ltd
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- urinalysis strips
- Primary DI
- 06971257037177
- Version / Model
- 3T
- Company Name
- Weihai Kangzheng Medical Equipment Technology Co., Ltd
- Labeler DUNS
- 554480344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-22
- Public Version
- 1
- Public Version Date
- 2024-07-01
- Public Version Status
- New
- Public Device Record Key
- 666f5650-46f4-41a4-a5e3-716da2ba9ef8
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | 862.1510 | 1 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30219 | Multiple urine analyte IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971257037177 | GS1 |