FDA UDI
In Commercial Distribution
🇺🇸 United States
IDG/Sanzay
DI: 00850053916250
·
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
- 00850053916250
- Version / Model
- 1
- Catalog Number
- QS31D
- Company Name
- IDG/SANZAY Corporation
- Labeler DUNS
- 948875013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-25
- Public Version
- 1
- Public Version Date
- 2024-07-03
- Public Version Status
- New
- Public Device Record Key
- 2d7a1c06-9f4d-4734-9b20-76798461179d
Device Description
The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol and low-density lipoprotein cholesterol for IDG HDL Cholesterol Enzymatic and LDL Cholesterol Enzymatic Assays, respectively. The calibrator is for in vitro diagnostic use only.
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 |
|---|---|---|---|---|
| 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 | 00850053916250 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072395 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius