FDA Registration
Active
🇺🇸 United States
AX-4280
Reg #: 1832816
·
FEI: 1832816
·
Expires 2025
Products
11
Proprietary Names
3
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- ARKRAY FACTORY USA, INC.
- Registration Number
- 1832816
- FEI Number
- 1832816
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- ZIP
- 33122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K013783
Owner / Operator
- Firm Name
- ARKRAY, INC.
- Operator Number
- 8030316
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- Postal Code
- 33122
- Country
- US
- Correspondent
- TOM - SPEIKERS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2011-07-26 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2011-07-26 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2011-07-26 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2011-07-26 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2011-07-26 |
Proprietary Names
AX-4280
AUTOMATED URINALYSIS SYSTEM
AUTION Sticks 9EB
Establishment Types
Complaint File Establishment per 21 CFR 820.198