FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NMR WASH Solution
DI: B3959910030
·
Model: 9910030
·
Labcorp of America
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- NMR WASH Solution
- Primary DI
- B3959910030
- Version / Model
- 9910030
- Catalog Number
- 9910030
- Company Name
- Labcorp of America
- Labeler DUNS
- 012822243
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-11
- Public Version
- 4
- Public Version Date
- 2019-09-25
- Public Version Status
- Update
- Public Device Record Key
- ec15c3cc-3d37-48fa-a188-08ebcfbce732
- Distribution End Date
- 2019-09-19
Device Description
WASH Solution used for the Vantera Clinical Analyzer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | Clinical Chemistry | 862.1475 | 1 |
| MRR | System, Test, Low Density, Lipoprotein | Clinical Chemistry | 862.1475 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | Clinical Chemistry | 862.1705 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57877 | Lipid profile analyser IVD, laboratory, automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of lipid profile analytes (cholesterol, fatty acids, lipids, lipoproteins and/or triglycerides) in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B3959910030 | HIBCC |
Customer Contacts
- Phone
- 919-256-1157
- [email protected]