FDA UDI
In Commercial Distribution
🇺🇸 United States
Audit MicroControls Linearity FD Cardiac Markers for Roche Systems
DI: B085K935M50
·
Model: K935M-5
·
AALTO SCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Audit MicroControls Linearity FD Cardiac Markers for Roche Systems
- Primary DI
- B085K935M50
- Version / Model
- K935M-5
- Company Name
- AALTO SCIENTIFIC
- Labeler DUNS
- 077974989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-07
- Public Version
- 1
- Public Version Date
- 2021-07-15
- Public Version Status
- New
- Public Device Record Key
- 34b418b5-5817-4c92-9fa8-df5f74c3c3ab
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
- 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
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 | B085K935M50 | HIBCC |