FDA UDI
In Commercial Distribution
🇺🇸 United States
Audit MicroControls Control LQ RF/CRP
DI: B085K073M60
·
Model: K073M-6
·
AALTO SCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Audit MicroControls Control LQ RF/CRP
- Primary DI
- B085K073M60
- Version / Model
- K073M-6
- Company Name
- AALTO SCIENTIFIC
- Labeler DUNS
- 077974989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-27
- Public Version
- 1
- Public Version Date
- 2018-04-27
- Public Version Status
- New
- Public Device Record Key
- f003c8e6-2c44-4dac-a39a-33d376dcb844
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 |
|---|---|---|---|---|
| 59938 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B085K073M60 | HIBCC |