FDA UDI
In Commercial Distribution
🇺🇸 United States
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207
DI: 00817302020489
·
Model: ST207
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207
- Primary DI
- 00817302020489
- Version / Model
- ST207
- Catalog Number
- ST207
- Company Name
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Labeler DUNS
- 962385787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f7c94d70-ecf0-4646-be4d-f3c1622d16de
Device Description
CK (Creatine Kinase) 4 x 300 tests
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| CGS | NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES | Clinical Chemistry | 862.1215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52989 | Creatine kinase (CK) multiple isoenzyme 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 qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302020489 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Kit contains 4 R1 and 4 R2 bottles and 1 package insert. | ||
| Total Volume | 56 | Milliliter | |
| Total Volume | 17 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable when stored at 2-8° C until expiration date
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius