Audit MicroControls Control LQ RF/CRP
- Primary DI
- B085K073M60
- Brand
- Audit MicroControls Control LQ RF/CRP
- Company
- AALTO SCIENTIFIC
- Model
- K073M-6
- 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 |
|---|
| B085K073M60 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Rheumatoid arthritis IVD, control | A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict rheumatoid arthritis. Rheumatoid arthritis is a chronic systemic inflammatory disease with autoimmune features which may be associated with multiple factors including HLA genotype, shared epitopes, polymorphisms in several genes (e.g., SLC22A4, PTPN8, MHC2TA), hormonal and environmental factors. |
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
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