FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10
DI: 00816068020481
·
Model: 3LA028
·
Advanced Instruments, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10
- Primary DI
- 00816068020481
- Version / Model
- 3LA028
- Catalog Number
- 3LA028
- Company Name
- Advanced Instruments, LLC
- Labeler DUNS
- 125006353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 2
- Public Version Date
- 2026-02-06
- Public Version Status
- Update
- Public Device Record Key
- 32c91c49-d1c0-44e8-97b7-484310d41dd5
Device Description
The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method.
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
- No
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 | 00816068020481 | GS1 |
Customer Contacts
- Phone
- +17813209000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius