FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTION EYE™ AI-4510 Analyzer
DI: 00015482188627
·
Model: 108861
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AUTION EYE™ AI-4510 Analyzer
- Primary DI
- 00015482188627
- Version / Model
- 108861
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-02
- Public Version
- 1
- Public Version Date
- 2024-12-10
- Public Version Status
- New
- Public Device Record Key
- db4aa709-b747-4883-9a28-4e9e34e2266d
Device Description
The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithilial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithilial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKM | Counter, Urine Particle | Hematology | 864.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35918 | Urine analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00015482188627 | GS1 |
Customer Contacts
- Phone
- 1-855-646-3108
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232416 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity