FDA UDI
In Commercial Distribution
🇺🇸 United States
Aution™ AU Control Solution
DI: 04987486738060
·
Model: 73806
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aution™ AU Control Solution
- Primary DI
- 04987486738060
- Version / Model
- 73806
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-25
- Public Version
- 1
- Public Version Date
- 2018-10-26
- Public Version Status
- New
- Public Device Record Key
- 6cb96b1a-b9f6-429b-bebc-ebcada002a0e
Device Description
Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30219 | Multiple urine analyte IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987486738060 | GS1 |
Customer Contacts
- Phone
- 1-855-646-3108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121456 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius