FDA UDI
In Commercial Distribution
🇺🇸 United States
Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820
DI: 00817302023213
·
Model: DT88820
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820
- Primary DI
- 00817302023213
- Version / Model
- DT88820
- Catalog Number
- DT88811
- Company Name
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Labeler DUNS
- 962385787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-08
- Public Version
- 1
- Public Version Date
- 2020-05-18
- Public Version Status
- New
- Public Device Record Key
- 3cfb56cf-ad59-4df7-9e18-32bed8c7a942
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
| CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE | Clinical Chemistry | 862.1170 | 2 |
| JIX | Calibrator, multi-analyte mixture | Clinical Chemistry | 862.1150 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59238 | Ion selective electrode (ISE) reference solution IVD, reagent | A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302023213 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Kit contains 2L of ISE Internal Standard Solution | ||
| Total Volume | 2 | Liter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable when stored unopened at 10-30° C until expiration date.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius