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Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10 FDA UDI
- Generic Name
- Osmolality IVD, calibrator FDA UDI
- Device Name
- Calibration standards are used to calibrate and/or check the performance of customer osmometers. FDA UDI
- Model / Reference
- 3LA201 FDA UDI
- Description
- Calibration standards are used to calibrate and/or check the performance of customer osmometers. FDA UDI
Identifiers
- Catalog Number
- 3LA201 FDA UDI
- Primary DI / UDI-DI
- 10816068020471 FDA UDI
- FDA Product Code
- JMZ FDA UDI
- GMDN Term
- Osmolality IVD, calibrator 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, calibrator
Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10 by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Osmolality IVD, calibrator.
- Precision Systems CON-TROL Cal Pack, 4 each: 100, 500 & 1500 mOsm 5 ml ampules — PRECISION SYSTEMS, INC. · Class I
- Precision Systems CON-TROL 1500, 5 ml ampules, 12/pk — PRECISION SYSTEMS, INC. · Class I
- Precision Systems CON-TROL 500, 5 ml ampules, 12/pk — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 2000 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 3000 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 100 mOsm Osmometry Standard — PRECISION SYSTEMS, INC. · Class I
- Precision Systems CON-TROL 100, 5 ml ampules, 12/pk — PRECISION SYSTEMS, INC. · Class I
- Precision Systems 2500 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 dd02c752-e19d-4e77-b93c-7db8405af1a2 36 fields · synced Jun 8, 2026