Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8

FDA UDI

Class I (US FDA UDI)

by Advanced Instruments, LLC

Identity

Trade Name: Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 FDA UDI
Generic Name: Osmolality IVD, control FDA UDI
Device Name: Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Renol urine controls are formulated to mimic reportable ranges (low-to-high levels) for urine. FDA UDI
Model / Reference: 3LA085 FDA UDI
Description: Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Renol urine controls are formulated to mimic reportable ranges (low-to-high levels) for urine. FDA UDI

Identifiers

Catalog Number: 3LA085 FDA UDI
Primary DI / UDI-DI: 00816068020290 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 Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 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 e6f7dd73-d690-4c49-aedb-c6e9fa68c252 36 fields · synced Jun 8, 2026