FDA UDI
In Commercial Distribution
🇺🇸 United States
Audit MicroControls Cal Ver FLQ Drugs of Abuse for Roche Systems
DI: B085K931M40
·
Model: K931M-4
·
AALTO SCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Audit MicroControls Cal Ver FLQ Drugs of Abuse for Roche Systems
- Primary DI
- B085K931M40
- Version / Model
- K931M-4
- Company Name
- AALTO SCIENTIFIC
- Labeler DUNS
- 077974989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-01
- Public Version
- 1
- Public Version Date
- 2020-04-09
- Public Version Status
- New
- Public Device Record Key
- 0abc9719-235e-4c54-b5df-04e67929c91d
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 |
|---|---|---|---|---|
| 30503 | Multiple therapeutic drugs/drugs of abuse 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 therapeutic drugs and drugs of abuse in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B085K931M40 | HIBCC |