FDA UDI
In Commercial Distribution
🇺🇸 United States
Cyclosporine C2 Control
DI: 00856743007055
·
Model: 202
·
MORE DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cyclosporine C2 Control
- Primary DI
- 00856743007055
- Version / Model
- 202
- Catalog Number
- 202
- Company Name
- MORE DIAGNOSTICS INC
- Labeler DUNS
- 829978451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-03
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 56c07116-5c84-48aa-98de-5d257a0fe0d0
Device Description
MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood.
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
- Yes
- 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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55440 | Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856743007055 | GS1 |
Customer Contacts
- Phone
- (800) 758-0978
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932662 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -14 Degrees Celsius