FDA UDI
In Commercial Distribution
🇺🇸 United States
Cholestech LDX™
DI: 00810039380307
·
Model: 14874
·
ALERE SAN DIEGO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cholestech LDX™
- Primary DI
- 00810039380307
- Version / Model
- 14874
- Catalog Number
- 14874
- 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
- 8df857e9-f3e8-4960-976c-241050d615fa
Device Description
Cholestech LDX™ Analyzer
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | Clinical Chemistry | 862.2170 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42625 | Photometric/spectroscopic immunoassay analyser IVD | An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810039380307 | GS1 |
Customer Contacts
- Phone
- +18774417440
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223179 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity