FDA Registration
Active
🇺🇸 United States
ARKRAY FACTORY USA, INC.
Reg #: 1832816
·
FEI: 1832816
·
Expires 2026
Products
32
Proprietary Names
58
Establishment Types
1
Classifications
32
Registration Details
- Registration Name
- ARKRAY FACTORY USA, INC.
- Registration Number
- 1832816
- FEI Number
- 1832816
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- ZIP
- 33122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151164
Owner / Operator
- Firm Name
- ARKRAY FACTORY USA, Inc.
- Operator Number
- 8030316
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- Postal Code
- 33122
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2015-11-03 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2024-09-30 |
| Counter, Urine Particle | LKM | Class 2 | Hematology | No | 2024-09-30 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2016-05-03 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2018-08-30 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-08-30 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-04-12 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2018-11-26 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2017-07-24 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2017-07-24 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2017-07-24 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2024-05-23 |
| Instrumentation, High Pressure Liquid Chromatography | LDM | Class 1 | Clinical Chemistry | No | 2026-03-04 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-02-14 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-09-12 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-09-12 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-06-27 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2024-09-10 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-09-10 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2024-09-10 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2024-09-10 |
| Injector, Pen | NSC | Class 2 | General Hospital | No | 2020-01-07 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2018-04-27 |
| Test, Time, Prothrombin | GJS | Class 2 | Hematology | No | 2023-02-17 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2015-05-28 |
| Prescription Use Blood Glucose Meter For Near-Patient Testing | PZI | Class 2 | Clinical Chemistry | No | 2024-09-26 |
Proprietary Names
Assure Prism Multi Blood Glucose Monitoring System
AUTION EYE AI-4510
ReliOn Premier BLU Blood Glucose Monitoring System
AUTION CHECK Plus
ReliOn Premier Compact Blood Glucose Monitoring System
TechLITE Pen Needles
GLUCOCARD 01 SENSOR PLUS Test Strips
GLUCOCARD 01 Blood Glucose Monitoring System
ReliOn Confirm Blood Glucose Monitoring System
ReliOn Confirm/Micro Plus Blood Glucose Test Strips
ReliOn Premier Voice Blood Glucose Monitoring System
ReliOn Premier Classic Blood Glucose Monitoring System
GLUCOCARD 01-mini
ReliOn micro
Assure Control Control Solution
GLUCOCARD Shine Blood Glucose Monitoring System
ADAMS A1c HA-8180V
Calibrator 80
Abacus 3CP 3-part WBC Differential Analyzer
Assure ID Safety Pen Needle
Assure Platinum BGM System
COLUMN UNIT 80; ELUENT 80A; ELUENT 80B; ELUENT 80CV; Hemolysis Washing Solution 80H; Control Dilution Set 80
ReliOn Prime BGM System
GLUCOCARD Vital BGM System
GLUCOCARD Vital Blood Glucose Test Strips
Assure Lance Plus Safety Lancets
Assure Lance Safety Lancets
TechLITE Lancet
Assure ID Safety Pen Needles
TechLITE PLUS Pen Needles
TechLITE Insulin Syringe
AUTION EYE Control Solution
AUTION EYE Sheath Solution
AUTION EYE Calibrator
GLUCOCARD Shine XL Blood Glucose Monitoring System
AUTION MAX AX-4060 Urinalysis System
AUTION Sticks 9EB
ReliOn Premier Lancing Device
Multi-Lancet Device 2
Abacus A5AS-1 5-part Laser WBC Differential Analyzer
Abacus 5-1 5-part Laser WBC Differential Analyzer
AUTOMATED URINALYSIS SYSTEM
AX-4280
Assure ID DUO-Shield Safety Pen Needles
GLUCOCARD Shine Connex Blood Glucose Monitoring System
GLUCOCARD Shine Express Blood Glucose Monitoring System
AUTION MAX AX-4030
SillHa paper Test Strip Kit
SillHa LH-4912 Oral Wellness System
Assure PT Care PT/INR Monitoring System
Concentrated Washing Solution 3
TechLITE Pen Needle
Assure Titanium Blood Glucose Monitoring System
S.G. Calibrator H
SteriLance Lancing Device LDE 4-AST
GLUCOCARD Expression Blood Glucose Monitoring System
AUTION Sticks 10EA Test Strips
AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System
Establishment Types
Complaint File Establishment per 21 CFR 820.198