FDA UDI
In Commercial Distribution
🇺🇸 United States
CEDIA Mycophenolic Acid Calibrators
DI: 00884883001817
·
Model: 100277
·
Microgenics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEDIA Mycophenolic Acid Calibrators
- Primary DI
- 00884883001817
- Version / Model
- 100277
- Company Name
- Microgenics Corporation
- Labeler DUNS
- 122153799
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2019-05-01
- Public Version Status
- Update
- Public Device Record Key
- 665abe20-5194-4503-9c69-47a14ca5acff
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DLJ | Calibrators, Drug Specific | Clinical Toxicology | 862.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55451 | Mycophenolate therapeutic drug monitoring IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug mycophenolate (Cellcept) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884883001817 | GS1 |