FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9
DI: 00816068020351
·
Model: 3MA028
·
ADVANCED INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9
- Primary DI
- 00816068020351
- Version / Model
- 3MA028
- Catalog Number
- 3MA028
- Company Name
- ADVANCED INSTRUMENTS, INC.
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- cd240adb-5579-4fe4-85c7-defff5a538be
Device Description
Protinol protein-based osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Protinol protein-based controls are formulated to mimic reportable ranges (low-to-high levels) for human serum.
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | Clinical Chemistry | 862.1540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52886 | Osmolality IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816068020351 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius