Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer

FDA UDI

Class I (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name: Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer FDA UDI
Generic Name: Osmometric analyser IVD FDA UDI
Device Name: Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel design that handles up to 20 samples, an intuitive touchscreen interface, and industry-leading performance. Simple, reliable, and efficient, the OsmoPRO delivers accurate and precise analysis of patient samples for maximum productivity. FDA UDI
Model / Reference: OsmoPRO FDA UDI
Description: Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel design that handles up to 20 samples, an intuitive touchscreen interface, and industry-leading performance. Simple, reliable, and efficient, the OsmoPRO delivers accurate and precise analysis of patient samples for maximum productivity. FDA UDI

Identifiers

Catalog Number: OsmoPRO FDA UDI
Primary DI / UDI-DI: 00816068020559 FDA UDI
FDA Product Code: JJM FDA UDI
GMDN Term: Osmometric analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Osmometric analyser IVD

Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 37d39722-005b-4da6-b485-4e3b4930679c 35 fields · synced Jun 8, 2026