FDA UDI
In Commercial Distribution
🇺🇸 United States
Cholestech LDX™
DI: 00893038002890
·
Model: 97987
·
ALERE SAN DIEGO, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cholestech LDX™
- Primary DI
- 00893038002890
- Version / Model
- 97987
- Catalog Number
- 97987
- Company Name
- ALERE SAN DIEGO, INC.
- Labeler DUNS
- 194854949
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 1
- Public Version Date
- 2023-12-28
- Public Version Status
- New
- Public Device Record Key
- 9a61b78c-e709-415a-87ed-2e6677cbac59
Device Description
Cholestech LDX™ TC HDL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | Clinical Chemistry | 862.1175 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | Clinical Chemistry | 862.1475 | 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 | 00893038002890 | GS1 |
Customer Contacts
- Phone
- +18774417440
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223179 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius