FDA.reportPublic FDA data

Osmolality IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.
GUDID devices
23
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00853539002041Osmolarity Normal Control SolutionsTearlab Corporation1000122024-01-05
00853539002058Osmolarity High Control SolutionTearlab Corporation1000132024-01-05
10816068020266Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 10Advanced Instruments, LLC3LA0292020-09-21
10816068020365Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0292020-09-21
B085K745M50Audit MicroControls Linearity LQ OsmolalityAALTO SCIENTIFICK745M-52026-04-30
10853539002048Osmolarity Normal Control SolutionsTearlab Corporation1000122024-01-05
10853539002055Osmolarity High Control SolutionTearlab Corporation1000132024-01-05
00850041049021Precision Systems 200 mOsm Osmometry StandardPrecision Systems, Inc.21022023-10-14
00850041049038Precision Systems 300 mOsm Osmometry StandardPrecision Systems, Inc.21032023-10-14
00850041049045Precision Systems 400 mOsm Osmometry StandardPrecision Systems, Inc.21042023-10-14
00850041049069Precision Systems 600 mOsm Osmometry StandardPrecision Systems, Inc.21062023-10-14
00850041049076Precision Systems 700 mOsm Osmometry StandardPrecision Systems, Inc.21072023-10-14
00850041049083Precision Systems 800 mOsm Osmometry StandardPrecision Systems, Inc.21082023-10-14
00850041049090Precision Systems 900 mOsm Osmometry StandardPrecision Systems, Inc.21092023-10-14
00850041049120Precision Systems 1200 mOsm Osmometry Standard, 250 mL bottlePrecision Systems, Inc.21122023-10-14
00850041049137Precision Systems 1300 mOsm Osmometry StandardPrecision Systems, Inc.21132023-10-14
00850041049595Precision Systems CON-TROL 290, 5 ml ampules, 12/pkPrecision Systems, Inc.22022023-10-14
03661540300196OSMOCOLL® HNL osmolality Controls, 6x1mLELITECHGROUP INC.SS-2732021-02-19
00816068020290Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8Advanced Instruments, LLC3LA0852020-09-21
00816068020351Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9Advanced Instruments, LLC3MA0282020-09-21
00816068020481Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA0282020-09-21
00816068020269Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 10ADVANCED INSTRUMENTS, INC.3LA0292020-09-21
00816068020368Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0292020-09-21