FDA Registration
Active
🇺🇸 United States
TOPTOLIFE DIAGNOSTICS LLC
Reg #: 3042471840
·
FEI: 3042471840
·
Expires 2026
Products
15
Proprietary Names
0
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- TOPTOLIFE DIAGNOSTICS LLC
- Registration Number
- 3042471840
- FEI Number
- 3042471840
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4023 Kennett Pike #50076
- City
- Wilmington
- State
- DE
- ZIP
- 19807
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162333
Owner / Operator
- Firm Name
- Toptolife Diagnostics LLC
- Operator Number
- 10094716
- Address
- 4023 Kennett Pike #50076
- City
- Wilmington
- State
- DE
- Postal Code
- 19807
- Country
- US
- Correspondent
- Airan Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2025-12-18 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2025-12-18 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2026-01-23 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2026-01-23 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2026-01-23 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2026-01-23 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2025-12-18 |
Establishment Types
Repack or Relabel Medical Device