FDA.reportPublic FDA data

Osmometric analyser IVD

Definition
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum, tears, sweat) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)].
GUDID devices
28
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00853539002188ScoutPro Osmolarity SystemTearlab Corporation1000942022-12-06
00841336107045Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCCASS-SS-162025-11-11
00841336107052Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCCASS-SS-82025-11-11
00841336107069Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCCASS-SS-MIR-42025-11-11
00841336107076Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCCASS-SS-PARTS-122025-11-11
00841336107083Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCCASS-SS-TORQ2025-11-11
00841336113107Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCBUR-BLOCK-THUMB-INSE2025-11-11
00850041049168OSMETTE III with Barcode Reader, 220VPrecision Systems, Inc.5010BF2023-10-14
00850041049182Multi-OSMETTE, Extended Range, 220VPrecision Systems, Inc.2430EF2023-10-14
00850041049199OSMETTE XL, 105VAC, JapanPrecision Systems, Inc.5007J2023-10-14
00850041049243OSMETTE XL, 105VAC, Japan, specialPrecision Systems, Inc.5007JS2023-10-14
00850041049632Multi-OSMETTEPrecision Systems, Inc.24302023-10-14
00850041049649Multi-OSMETTEPrecision Systems, Inc.2430E2023-10-14
00850041049656Multi-OSMETTEPrecision Systems, Inc.2430F2023-10-14
00850041049694OSMETTE APrecision Systems, Inc.50022023-10-14
00850041049700OSMETTE APrecision Systems, Inc.5002F2023-10-14
00850041049717Micro-OSMETTEPrecision Systems, Inc.50042023-10-14
00850041049724Micro-OSMETTEPrecision Systems, Inc.5004F2023-10-14
00850041049748Milk CRYETTEPrecision Systems, Inc.5006F2023-10-14
00850041049755OSMETTE XLPrecision Systems, Inc.50072023-10-14
00850041049762OSMETTE XL with Barcode ReaderPrecision Systems, Inc.5007B2023-10-14
00850041049779OSMETTE XLPrecision Systems, Inc.5007F2023-10-14
00850041049823OSMETTE IIIPrecision Systems, Inc.50102023-10-14
00850041049830OSMETTE III with Barcode ReaderPrecision Systems, Inc.5010B2023-10-14
00850041049847OSMETTE IIIPrecision Systems, Inc.5010F2023-10-14
00850041049861Touch Micro-OSMETTEPrecision Systems, Inc.60022023-10-14
00850041049878Touch Micro-OSMETTE with Printer and Data outputPrecision Systems, Inc.60032023-10-14
10853539002185ScoutPro Osmolarity SystemTearlab Corporation1000942022-12-06