FDA UDI
In Commercial Distribution
🇺🇸 United States
Solomon Commutable Quality Materials
DI: 00850083817015
·
Model: 20001LRCH
·
Solomon Park Research Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solomon Commutable Quality Materials
- Primary DI
- 00850083817015
- Version / Model
- 20001LRCH
- Catalog Number
- 20001LRCH
- Company Name
- Solomon Park Research Laboratories, Inc.
- Labeler DUNS
- 943785295
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-06
- Public Version
- 1
- Public Version Date
- 2026-04-14
- Public Version Status
- New
- Public Device Record Key
- d414b3d5-8e28-4178-b5a2-3e74292463a4
Device Description
LRC - Lipid Reference Value Control High
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47868 | Multiple-type clinical chemistry analyte profile IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850083817015 | GS1 |
Customer Contacts
- Phone
- 425-650-2000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.6 | Milliliter | |
| Device Size Text, specify | 1 vial |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -85 – -65 Degrees Celsius