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Advanced Instruments Osmo1® Single-Sample Micro-Osmometer

FDA UDI

Class I (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name
Advanced Instruments Osmo1® Single-Sample Micro-Osmometer FDA UDI
Generic Name
Osmometric analyser IVD, semi-automated FDA UDI
Device Name
With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument. FDA UDI
Model / Reference
Osmo1 FDA UDI
Description
With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument. FDA UDI

Identifiers

Catalog Number
Osmo1 FDA UDI
Primary DI / UDI-DI
00816068020542 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Osmometric analyser IVD, semi-automated

Advanced Instruments Osmo1® 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Instruments, LLC

Sources (1)

  • FDA UDI 0a6c135a-2481-416e-bf76-2825d3329e03 35 fields · synced Jun 8, 2026