FDA UDI
In Commercial Distribution
🇺🇸 United States
STANDARD™ LipidoCare Analyzer
DI: 00887473000320
·
Model: 02LA10G
·
SD Biosensor, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STANDARD™ LipidoCare Analyzer
- Primary DI
- 00887473000320
- Version / Model
- 02LA10G
- Company Name
- SD Biosensor, Inc.
- Labeler DUNS
- 557812789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-07
- Public Version
- 2
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7adcc658-6403-4292-8b2a-cb1ed086d7bf
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | Clinical Chemistry | 862.1175 | 1 |
| JGY | Colorimetric Method, Triglycerides | Clinical Chemistry | 862.1705 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | Clinical Chemistry | 862.1475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53359 | Total cholesterol lipid IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cholesterol lipid in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887473000320 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160282 | 000 |