FDA.reportPublic FDA data

Isotonic saline reagent IVD

Definition
An unbuffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.
GUDID devices
26
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00848838091322Sensititre Saline- Tween w/ Glass BeadsREMEL, INC.T3491 2024-02-22
00851683007318YSI IncorporatedYSI INCORPORATED2392C2026-04-28
04038917554633Screw Cap Tube 101x16 RBS with salineSARSTEDT, INC.51.540.3872022-12-04
04038917554671Screw Cap Tube 82x13 FB with salineSARSTEDT, INC.51.550.1232022-12-04
04038917952569Screw Cap Tube 79x16 RB with salineSARSTEDT, INC.51.506.3902022-12-04
08719189137477RPI-CheckMechatronics USA LLCA00169122022-12-05
00810144911304RediporAnalytiChem USA, Inc.12023-09-28
00810144911168RediporAnalytiChem USA, Inc.12023-09-21
00810144911175RediporAnalytiChem USA, Inc.12023-09-21
00810144911182RediporAnalytiChem USA, Inc.12023-09-21
00810144911199RediporAnalytiChem USA, Inc.12023-09-21
00810144911205RediporAnalytiChem USA, Inc.12023-09-21
00810144911212RediporAnalytiChem USA, Inc.12023-09-21
08719189137347RPIMechatronics USA LLCA00215872022-12-05
08719189137538RPI-CheckMechatronics USA LLCA00169122022-12-05
04038917554640Screw Cap Tube 101x16 RBS with salineSARSTEDT, INC.51.540.3872022-12-04
04038917554688Screw Cap Tube 82x13 FB with salineSARSTEDT, INC.51.550.1232022-12-04
04038917952552Screw Cap Tube 79x16 RB with salineSARSTEDT, INC.51.506.3902022-12-04
05032384028610RINGERS SOLUTION TABLETS (100'S)OXOID LIMITEDBR0052G2022-12-04
00845275004366Thermo Scientific Nerl®Fisher Diagnostics9800-32019-08-26
00857969006624ACEALFA WASSERMANN, INC.SA10202020-04-09
05055273206111NSRANDOX LABORATORIES LIMITEDSA38542016-09-26
05055273209389NSRANDOX LABORATORIES LIMITEDSA83962016-09-26
00847865001731Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.310982016-09-12
00851683007011YSI IncorporatedYSI INCORPORATED23922016-12-31
00630140058861SPCardinal Health 200, LLCB5052-252018-12-27