FDA UDI
In Commercial Distribution
🇺🇸 United States
PTS Panels® Triglycerides Test Strips
DI: 00381931789012
·
Model: 1789
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- PTS Panels® Triglycerides Test Strips
- Primary DI
- 00381931789012
- Version / Model
- 1789
- Catalog Number
- 1789
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-07-22
- Public Version
- 5
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 04500ff2-0de2-46ce-9ce6-907fdf6da0f7
Device Description
PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
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 |
|---|---|---|---|---|
| JGY | COLORIMETRIC METHOD, TRIGLYCERIDES | Clinical Chemistry | 862.1705 | 1 |
| CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | Clinical Chemistry | 862.1705 | 1 |
| NGO | TEST, TRIGLYCERIDES, OVER THE COUNTER | Clinical Chemistry | 862.1705 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53462 | Triglyceride IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of triglycerides in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00381931789012 | GS1 | ||||
| Unit of Use | 10381931789019 | GS1 |
Customer Contacts
- Phone
- +1(877)870-5610
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 86 Degrees Fahrenheit