FDA Registration
Active
🇺🇸 United States
Cholestech LDX
Reg #: 2027969
·
FEI: 1000125596
·
Expires 2025
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Alere San Diego, Inc.
- Registration Number
- 2027969
- FEI Number
- 1000125596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9942 Mesa Rim Road
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120615
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2013-05-20 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2013-05-20 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2013-05-20 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2013-05-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2013-05-20 |
Proprietary Names
Cholestech LDX
Cholestech LDX TC HDL GLU
Cholestech LDX Lipid Profile GLU
Cholestech LDX Analyzer
Cholestech LDX TC HDL
Cholestech LDX TC
Cholestech LDX TC GLU
Cholestech LDXLipid Profile
Establishment Types
Manufacture Medical Device