FDA.reportPublic FDA data

MX3 Hydration Testing System

Primary DI
00860016483507
Brand
MX3 Hydration Testing System
Company
MX3 DIAGNOSTICS PTY LTD
Model
LAB PRO HYPRO18
Device description
A battery-powered, hand-held, portable instrument intended to be used for a personal's hydration status via the in vivo measurement of the osmolarity of saliva.
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JJMOsmometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJMOsmometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016483507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016483507008600164835078600164835070860016483507

GMDN Terms#

Term, Definition table
TermDefinition
Tear osmolarity meterA battery-powered, hand-held, portable instrument intended to be used for the in vivo measurement of the osmolarity of tears, to facilitate diagnosis of ocular surface disorders. It is used to take a sample of the tear film and typically makes the measurement using electrical impedance on a single-use electrode test strip inserted into the meter.

Regulatory Flags#

DUNS number
744607390
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850041049144Probe for Micro-OSMETTEPrecision Systems, Inc.JJM2023-10-14
00850041049168OSMETTE III with Barcode Reader, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049175Probe for Multi-OSMETTE Precision Systems, Inc.JJM2023-10-14
00850041049182Multi-OSMETTE, Extended Range, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049199OSMETTE XL, 105VAC, JapanPrecision Systems, Inc.JJM2023-10-14
00850041049212OSMETTE Sample Tubes, 2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049229OSMETTE Sample Tubes, 0.2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049236Micro-OSMETTE Sample Tubes, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049243OSMETTE XL, 105VAC, Japan, specialPrecision Systems, Inc.JJM2023-10-14
00850041049267OSMETTE Pipettor, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049281Clearview Disp Sample Tubes, 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049311CRYETTE Stir Wires, for 2 ml tubes, 4/pkPrecision Systems, Inc.JJM2023-10-14
00850041049328OSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049335Micro-OSMETTE Stir Wires for 50 ul samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049366OSMETTE III 10 ul Pipet Piston 2/pkPrecision Systems, Inc.JJM2023-10-14
00850041049373OSMETTE III Plunger Tip WirePrecision Systems, Inc.JJM2023-10-14
00850041049380OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
00850041049410OSMETTE Sample Tube Rack for 2.0 & 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049427Multi-OSMETTE Carousel, SparePrecision Systems, Inc.JJM2023-10-14
00850041049434Multi-OSMETTE Evaporation ShieldPrecision Systems, Inc.JJM2023-10-14
00850041049441OSMETTE Sample Tube Rack, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049489OSMETTE III Pipette Tips & CLEANETTEs, 1/M ea/pkPrecision Systems, Inc.JJM2023-10-14
00850041049502OSMETTE Probe 0.2 & 2.0 mlPrecision Systems, Inc.JJM2023-10-14
00850041049519Touch Micro-OSMETTE ProbePrecision Systems, Inc.JJM2023-10-14
00850041049526OSMETTE III ProbePrecision Systems, Inc.JJM2023-10-14
00850041049533OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
0085004104954010 ul Pipettor for OSMETTE IIIPrecision Systems, Inc.JJM2023-10-14
00850041049557OSMETTE Pipette Tips 1000/pkg 30 - 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049564OSMETTE Printer RibbonPrecision Systems, Inc.JJM2023-10-14
00850041049571OSMETTE Bath Liquid, 250mlPrecision Systems, Inc.JJM2023-10-14