FDA.reportPublic FDA data

Osmolality IVD, calibrator

Definition
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.
GUDID devices
62
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816068020986Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0032020-09-21
04260341780566GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.01002021-05-07
04260341780573GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.05002021-05-07
04260341780580GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.08502021-05-07
04260341780597GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.20002021-05-07
04260341780603GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1mlG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.02902021-05-07
10816068020303Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA2002020-09-21
10816068020310Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0052020-09-21
10816068020372Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0852020-09-21
10816068020433Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA0112020-09-21
10816068020440Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA1512020-09-21
10816068020457Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA0512020-09-21
10816068020464Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA0912020-09-21
10816068020471Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA2012020-09-21
10816068020747Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 10Advanced Instruments, LLC3LA3012020-09-21
10816068020754Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0002020-09-21
10816068020761Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0202020-09-21
10816068020778Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA0402020-09-21
10816068020785Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA1002020-09-21
10816068020990Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10Advanced Instruments, LLC3MA4002020-09-21
00850041049014Precision Systems 100 mOsm Osmometry StandardPrecision Systems, Inc.21012023-10-14
00850041049052Precision Systems 500 mOsm Osmometry Standard, 125 mL bottlePrecision Systems, Inc.21052023-10-14
00850041049106Precision Systems 1000 mOsm Osmometry StandardPrecision Systems, Inc.21102023-10-14
00850041049113Precision Systems 1100 mOsm Osmometry StandardPrecision Systems, Inc.21112023-10-14
00850041049151Precision Systems 1500 mOsm Osmometry StandardPrecision Systems, Inc.21152023-10-14
00850041049205Precision Systems 2000 mOsm Osmometry StandardPrecision Systems, Inc.21202023-10-14
00850041049250Precision Systems 2500 mOsm Osmometry StandardPrecision Systems, Inc.21252023-10-14
00850041049304Precision Systems 3000 mOsm Osmometry StandardPrecision Systems, Inc.21302023-10-14
00850041049588Precision Systems CON-TROL 100, 5 ml ampules, 12/pkPrecision Systems, Inc.22012023-10-14
00850041049601Precision Systems CON-TROL 500, 5 ml ampules, 12/pkPrecision Systems, Inc.22052023-10-14
00850041049618Precision Systems CON-TROL 1500, 5 ml ampules, 12/pkPrecision Systems, Inc.22152023-10-14
00850041049625Precision Systems CON-TROL Cal Pack, 4 each: 100, 500 & 1500 mOsm 5 ml ampulesPrecision Systems, Inc.22632023-10-14
00850041049007Precision Systems 0 mOsm Osmometry StandardPrecision Systems, Inc.20002023-09-29
04260341780559GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.00202021-05-07
04260341780726GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.01002021-05-07
04260341780733GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.05002021-05-07
04260341780740GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.08502021-05-07
04260341780757GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mLG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.20002021-05-07
04260341780764GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1mlG o n o t e c Gesellschaft für Meß- und Regeltechnik mbH.30.9.02902021-05-07
03661540301483OPTIMOLE™ Osmolality Standard, 100 mmol/kg, 60x.4mLELITECHGROUP INC.OA-0102021-02-19
03661540301490OPTIMOLE™ Osmolality Standard, 290 mmol/kg, 60x.4mLELITECHGROUP INC.OA-2902021-02-19
03661540301506OPTIMOLE™ Osmolality Standard, 1000 mmol/kg, 60x.4mLELITECHGROUP INC.OA-1002021-02-19
00816068020702Advanced Instruments 100 mOsm Calibration Standard - 110 mL BottleAdvanced Instruments, LLC3LA0102020-09-21
00816068020719Advanced Instruments 500 mOsm Calibration Standard - 110 mL BottleAdvanced Instruments, LLC3LA0502020-09-21
00816068020726Advanced Instruments 900 mOsm Calibration Standard - 110 mL BottleAdvanced Instruments, LLC3LA0902020-09-21
00816068020733Advanced Instruments 1500 mOsm Calibration Standard - 110 mL BottleAdvanced Instruments, LLC3LA1502020-09-21
00816068020894Advanced Instruments Bin Setting Fluid – 10 mLAdvanced Instruments, LLC3LA0092020-09-21
00816068020979Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0032020-09-21
00816068020306Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA2002020-09-21
00816068020313Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0052020-09-21
00816068020375Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0852020-09-21
00816068020436Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3LA0112020-09-21
00816068020443Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3LA1512020-09-21
00816068020450Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3LA0512020-09-21
00816068020467Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3LA0912020-09-21
00816068020474Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3LA2012020-09-21
00816068020740Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3LA3012020-09-21
00816068020757Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0002020-09-21
00816068020764Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0202020-09-21
00816068020771Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA0402020-09-21
00816068020788Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA1002020-09-21
00816068020993Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10ADVANCED INSTRUMENTS, INC.3MA4002020-09-21