Fiske 210 Single-Sample Micro-Osmometer

FDA UDI

Class I (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name: Fiske 210 Single-Sample Micro-Osmometer FDA UDI
Generic Name: Osmometric analyser IVD, semi-automated FDA UDI
Device Name: The Fiske 210 Single-Sample Micro-Osmometer is designed for routine osmolality measurement in clinical, pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-2000 mOsm. FDA UDI
Model / Reference: 210 FDA UDI
Description: The Fiske 210 Single-Sample Micro-Osmometer is designed for routine osmolality measurement in clinical, pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-2000 mOsm. FDA UDI

Identifiers

Catalog Number: 210 FDA UDI
Primary DI / UDI-DI: 00816068020863 FDA UDI
FDA Product Code: JJM FDA UDI
GMDN Term: Osmometric analyser IVD, semi-automated 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

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Osmometric analyser IVD, semi-automated

Fiske 210 Single-Sample Micro-Osmometer by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osmometric analyser IVD, semi-automated.

Advanced Instruments Model 3250 Single-Sample Osmometer — Advanced Instruments, LLC · Class I
Advanced Instruments Osmo1® Single-Sample Micro-Osmometer — Advanced Instruments, LLC · 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 f3cd8763-c445-424f-9301-c36b77a36323 35 fields · synced Jun 8, 2026