FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PTS Panels® Ketones Test Strips
DI: 00381931718012
·
Model: 1718
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- PTS Panels® Ketones Test Strips
- Primary DI
- 00381931718012
- Version / Model
- 1718
- Catalog Number
- 1718
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 5
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- df50c36b-adf2-4b1c-82b9-f240fe1fc1d8
- Distribution End Date
- 2017-01-20
Device Description
PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone 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)
- Yes
- 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 |
|---|---|---|---|---|
| JMK | ACID, ALPHA-KETOBUTYRIC AND NADH (U.V.), HYDROXYBUTYRIC DEHYDROGENASE | Clinical Chemistry | 862.1380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47002 | Ketone (acetoacetate) 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 ketone (acetoacetate) in a clinical specimen 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. 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 | 00381931718012 | GS1 | ||||
| Unit of Use | 10381931718019 | GS1 |
Customer Contacts
- Phone
- +1(877)870-5610
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius