Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10

FDA UDI

Class I (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name: Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10 FDA UDI
Generic Name: Osmolality IVD, control FDA UDI
Device Name: The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method. FDA UDI
Model / Reference: 3LA028 FDA UDI
Description: The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method. FDA UDI

Identifiers

Catalog Number: 3LA028 FDA UDI
Primary DI / UDI-DI: 00816068020481 FDA UDI
FDA Product Code: JMZ FDA UDI
GMDN Term: Osmolality IVD, control 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

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Osmolality IVD, control

Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10 by Advanced Instruments, LLC — Class I — FDA UDI — listed in FDA GUDID

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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 32c91c49-d1c0-44e8-97b7-484310d41dd5 36 fields · synced Jun 8, 2026