FDA UDI
In Commercial Distribution
🇺🇸 United States
LipidPlus® Total Cholesterol Test Strips
DI: 10763924532107
·
Model: MD532
·
JANT PHARMACAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LipidPlus® Total Cholesterol Test Strips
- Primary DI
- 10763924532107
- Version / Model
- MD532
- Company Name
- JANT PHARMACAL CORPORATION
- Labeler DUNS
- 797393659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-16
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- bf0bce25-636a-4131-aa61-68616b49360a
Device Description
Lipid and Glucose Measuring System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30222 | Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10763924532107 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130295 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Microliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit