FDA UDI
In Commercial Distribution
🇺🇸 United States
pts panels® Multi-Chemistry Controls
DI: 00381930721013
·
Model: 721
·
POLYMER TECHNOLOGY SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- pts panels® Multi-Chemistry Controls
- Primary DI
- 00381930721013
- Version / Model
- 721
- Catalog Number
- 721
- Company Name
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Labeler DUNS
- 835772872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-18
- Public Version
- 4
- Public Version Date
- 2023-01-23
- Public Version Status
- Update
- Public Device Record Key
- 877d571e-d722-4be9-b993-0cde588e9711
Device Description
PTS PANELS® Multi-Chemistry Controls contain cholesterol, triglycerides, glucose, and ketones. The analyte(s) in this solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with the controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJY | Multi-analyte controls, all kinds (assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47869 | Multiple-type clinical chemistry analyte profile IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00381930721013 | GS1 |
Customer Contacts
- Phone
- +1(888)877-5610
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Recap after using.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Use care not to contaminate dropper tip.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use beyond the expiration date on the vial.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Opened product is stable for at least ten months at room temperature.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Product is ready to use and is clear.
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 46 Degrees Fahrenheit