FDA UDI
In Commercial Distribution
🇺🇸 United States
TECO DIAGNOSTICS
DI: 10673486000412
·
Model: URS-2L-POUCH-G
·
TECO DIAGNOSTICS
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TECO DIAGNOSTICS
- Primary DI
- 10673486000412
- Version / Model
- URS-2L-POUCH-G
- Catalog Number
- URS-2L-POUCH-G
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 7
- Public Version Date
- 2023-04-24
- Public Version Status
- Update
- Public Device Record Key
- f53c164a-4961-4160-82d3-a8d798d369b7
Device Description
URS 2L POUCH (UTI POUCH)
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
- 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 |
|---|---|---|---|---|
| LJX | Test, Urine Leukocyte | Hematology | 864.7675 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | 862.1510 | 1 |
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 | 10673486000412 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100024 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius