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Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9 FDA UDI
- Generic Name
- Osmolality IVD, control FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3MA028 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 3MA028 FDA UDI
- Primary DI / UDI-DI
- 00816068020351 FDA UDI
- FDA Product Code
- JMZ FDA UDI
- GMDN Term
- Osmolality IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Osmolality IVD, control
Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9 by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Osmolality IVD, control.
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- Precision Systems 1300 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 800 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advanced Instruments, LLC
Sources (1)
- FDA UDI cd240adb-5579-4fe4-85c7-defff5a538be 36 fields · synced Jun 8, 2026