Audit MicroControls Linearity FD Cardiac RAMP
- Primary DI
- B085K887M50
- Brand
- Audit MicroControls Linearity FD Cardiac RAMP
- Company
- AALTO SCIENTIFIC
- Model
- K887M-5
- Published
- 2018-03-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B085K887M50 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 077974989
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| B085K924M100 | Audit MicroControls Linearity FD Tumor Markers for Roche Systems | K924M-10 | | 2025-12-18 |
| B085K087M60 | Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies | K087M-6 | | 2020-11-12 |
| B085K932M50 | Audit MicroControls Linearity FLQ Troponin T for Roche Systems | K932M-5 | | 2020-11-03 |
| B085K815M50 | Audit MicroControls Linearity FD ISE for Siemens Atellica | K815M-5 | | 2025-11-26 |
| B085K939M100 | Audit MicroControls Linearity FD Tumor Markers for Abbott Systems | K939M-10 | | 2025-11-26 |
| B085K743M50 | Audit MicroControls Linearity FD Lipoprotein (a) | K743M-5 | | 2025-11-20 |
| B085K829M100 | Audit MicroControls Linearity FD Urine Chemistry for Beckman AU | K829M-10 | | 2025-11-20 |
| B085K922M50 | Audit MicroControls Linearity FLQ Special Diabetes for Roche Systems | K922M-5 | | 2024-12-16 |
| B085K836M50 | Audit MicroControls Linearity FD BNP for Abbott Systems | K836M-5 | | 2025-07-22 |
| B085K830M50 | Audit MicroControls Linearity LQ Ammonia/Alcohol for Ortho Vitros | K830M-5 | | 2025-07-10 |
| B085K762M50 | Audit MicroControls Linearity LQ Special Proteins | K762M-5 | | 2025-04-28 |
| B085K739M100 | Audit MicroControls Linearity FD Traumatic Brain Injury (TBI) | K739M-10 | | 2025-04-10 |
| B085K742M50 | Audit MicroControls Linearity FD Bilirubin | K742M-5 | | 2025-04-10 |
| B085K864M50 | Audit MicroControls Linearity FD General Chemistry Panel 1 for Alfa Wassermann | K864M-5 | | 2025-03-06 |
| B085K865M50 | Audit MicroControls Linearity FD General Chemistry Panel 2 for Alfa Wassermann | K865M-5 | | 2025-03-06 |
| B085K866M50 | Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa Wassermann | K866M-5 | | 2025-03-06 |
| B085K867M100 | Audit MicroControls Linearity FD General Chemistry Panel 4 for Alfa Wassermann | K867M-10 | | 2025-03-06 |
| B085K061M60 | Audit MicroControls Control FD HbA1c | K061M-6 | | 2018-03-27 |
| B085K852M200 | Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1) | K852M-20 | | 2025-01-06 |
| B085K846M100 | Audit MicroControls Linearity FD GFAP, UCH-L1 for bioMérieux VIDAS® TBI (GFAP, U | K846M-10 | | 2024-12-06 |