FDA UDI
In Commercial Distribution
🇺🇸 United States
IDG/Sanzay
DI: 00850053916175
·
Model: 1
·
IDG/SANZAY Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDG/Sanzay
- Primary DI
- 00850053916175
- Version / Model
- 1
- Catalog Number
- C501
- Company Name
- IDG/SANZAY Corporation
- Labeler DUNS
- 948875013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-12
- Public Version
- 1
- Public Version Date
- 2024-01-22
- Public Version Status
- New
- Public Device Record Key
- 17444410-bdd7-48d5-a15e-691eb53c55fd
Device Description
The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | Clinical Chemistry | 862.1475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53393 | High density lipoprotein (HDL) cholesterol IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850053916175 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 80 | Milliliter | |
| Total Volume | 380 | Milliliter | |
| Total Volume | 1 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius