FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cardiac CalVer for Abbott Systems, Level A-E
DI: 00817238010028
·
Model: 98602
·
CLINIQA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cardiac CalVer for Abbott Systems, Level A-E
- Primary DI
- 00817238010028
- Version / Model
- 98602
- Company Name
- CLINIQA CORPORATION
- Labeler DUNS
- 078742335
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 2
- Public Version Date
- 2020-08-31
- Public Version Status
- Update
- Public Device Record Key
- de7a5774-f0b2-4446-9cc3-7e86d1eed62d
- Distribution End Date
- 2020-08-31
Device Description
LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott Systems, Level D LiniCAL Cardiac CalVer for Abbott Systems, Level E
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47016 | Multiple cardiac marker 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 one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817238010028 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080973 | 000 |