FDA UDI
In Commercial Distribution
🇺🇸 United States
Lipoprint System Buffer 4x16.5g
DI: 00896863002325
·
Model: 48-9519
·
QUANTIMETRIX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lipoprint System Buffer 4x16.5g
- Primary DI
- 00896863002325
- Version / Model
- 48-9519
- Catalog Number
- 48-9519
- Company Name
- QUANTIMETRIX CORPORATION
- Labeler DUNS
- 010717890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-26
- Public Version
- 1
- Public Version Date
- 2018-10-29
- Public Version Status
- New
- Public Device Record Key
- 9bb61003-7b06-496e-bfc2-57a0d5e65adb
Device Description
The Lipoprint System Buffer is intended to be used as an electrolyte buffer solution in conjunction with Quantimetrix Lipoprint LDL and HDL reagent kits. It is a mixture of Tris (hydroxymethyl) aminomethane and Boric Acid crystals.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
| JHO | Electrophoretic Separation, Lipoproteins | Clinical Chemistry | 862.1475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42693 | pH-adjusted buffer solution IVD | A pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M0514895191 | HIBCC | ||||
| Primary | 00896863002325 | GS1 |
Customer Contacts
- Phone
- (310) 536-0006
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius