Identity
- Trade Name
- Advanced Instruments Bin Setting Fluid – 10 mL FDA UDI
- Generic Name
- Osmolality IVD, calibrator FDA UDI
- Device Name
- Bin-Setting Fluid (10 mL ampoule) for use with select Advanced Instruments' instruments FDA UDI
- Model / Reference
- 3LA009 FDA UDI
- Description
- Bin-Setting Fluid (10 mL ampoule) for use with select Advanced Instruments' instruments FDA UDI
Identifiers
- Catalog Number
- 3LA009 FDA UDI
- Primary DI / UDI-DI
- 00816068020894 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 Bin Setting Fluid – 10 mL by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osmolality IVD, calibrator.
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- 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 72761191-c09c-4619-a29b-1b5b99bef49a 36 fields · synced Jun 8, 2026