FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Alere Cholestech LDX®
DI: 00893038002630
·
Model: 10-989
·
ALERE SAN DIEGO, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alere Cholestech LDX®
- Primary DI
- 00893038002630
- Version / Model
- 10-989
- Catalog Number
- 10-989
- Company Name
- ALERE SAN DIEGO, INC.
- Labeler DUNS
- 194854949
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-29
- Public Version
- 4
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- cd21d3a4-7fe9-44d3-9df3-ea9e65eb0a09
- Distribution End Date
- 2022-05-26
Device Description
Alere Cholestech LDX® Lipid Profile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JGY | Colorimetric Method, Triglycerides | Clinical Chemistry | 862.1705 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | Clinical Chemistry | 862.1475 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | Clinical Chemistry | 862.1175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53357 | Multiple lipid analyte IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893038002630 | GS1 |
Customer Contacts
- Phone
- +18773088289
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius