FDA Registration
Active
🇨🇳 China
Changchun LYZ Technology Co.,LTD
Reg #: 3024171133
·
FEI: 3024171133
·
Expires 2026
Products
16
Proprietary Names
20
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- Changchun LYZ Technology Co.,LTD
- Registration Number
- 3024171133
- FEI Number
- 3024171133
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 601.602, 6th Floor, Plant 3#, Construction Project of Sealed molding Products, 899 Yueda Road, High-tech Development Zone
- City
- Changchun City Jilin
- Country
- CN
Owner / Operator
- Firm Name
- Changchun LYZ Technology Co.,LTD
- Operator Number
- 10087523
- Address
- Room 601.602, 6th Floor, Plant 3#, Construction Project of Sealed molding Products, 899 Yueda Road, High-tech Development Zone
- City
- Changchun City
- State
- Jilin
- Postal Code
- 130102
- Country
- CN
- Correspondent
- Paul Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2023-03-10 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2023-03-10 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2023-03-10 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2024-10-22 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2023-03-10 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2023-03-10 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2024-10-22 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2024-10-22 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2023-03-10 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2024-10-25 |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2023-03-10 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2024-10-22 |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | Class 1 | Microbiology | No | 2024-10-25 |
| Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells | NTR | Class 1 | Hematology | No | 2024-10-22 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2024-10-22 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2024-10-22 |
Proprietary Names
NITRITE, Urine Test Strips, UTI Test Strips
PROTEIN, Urine Test Strips, MICROALBUMIN, Urine Test Strips
VAGINAL pH Test Strips
UROBILINOGEN, Urine Test Strips
LEUKOCYTES, Urine Test Strips, UTI Test Strips
KETONE, Urine Test Strips
SG, SPECIFIC GRAVITY, Urine Test Strips
Lead Test Swabs
Food Test Strips, Pesticide Residue Test Cards, Water Test Machine, Blood Glucose Meter, Blood Pressure Meter, Oximeter,
Nebulizer, Thermometer, Varicose Socks), Soil Nitrogen Test Strips, Soil Phosphorus Test Strips,
EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE (Oil Test Strips,
Soil Potassium Test Strips
FSH Rapid test Kits
Pet Test Strips
pH, Urine Test Strips, UTI Test Strips
Chlorine test strips
Water Test Strips, Hardness Test Strips, Pool Test Strips, Aquarium Test Strips, Drinking Water Test Strips,
Rapid Test Kits, Drug Rapid Test Kits, HIV Rapid Test Kits, Alcohol Test Strips
ASCORBIC ACID, Urine Test Strips
BILIRUBIN, Urine Test Strips
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device