FDA UDI
In Commercial Distribution
🇺🇸 United States
Audit MicroControls Linearity FLQ General Chemistry Panel 2 for Roche Systems
DI: B085K918M50
·
Model: K918M-5
·
AALTO SCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Audit MicroControls Linearity FLQ General Chemistry Panel 2 for Roche Systems
- Primary DI
- B085K918M50
- Version / Model
- K918M-5
- Company Name
- AALTO SCIENTIFIC
- Labeler DUNS
- 077974989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-02
- Public Version
- 1
- Public Version Date
- 2022-03-10
- Public Version Status
- New
- Public Device Record Key
- ddb8d64e-9538-4b76-b0e3-bd0c1d83cb81
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 |
|---|---|---|---|---|
| 47869 | Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B085K918M50 | HIBCC |