FDA.reportPublic FDA data

Lactate IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of lactate in a clinical specimen.
GUDID devices
18
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816042014543FORAFORA CARE INC.Test N'GO Advance Voice2025-05-06
00851683007349YSI IncorporatedYSI INCORPORATED2329C2026-04-28
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONLactate Plus2022-12-08
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.TD-42892024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.TD-42892024-07-08
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.TD-42892023-08-08
06971674866756BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:60mL×2 R2:20mL×22023-07-22
06971674866763BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:18mL×4 R2:6mL×42023-07-22
06971674866770BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:18mL×1 R2:6mL×12023-07-22
10758750004454VITROSORTHO-CLINICAL DIAGNOSTICS, INC.81501122020-04-18
10758750004911VITROSORTHO-CLINICAL DIAGNOSTICS, INC.84338802020-04-18
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.400-00372016-09-23
05391516742290Trinity Biotech TRINITY BIOTECH PUBLIC LIMITED COMPANY826-102016-09-23
00851683007097YSI IncorporatedYSI INCORPORATED23252016-09-26
00851683007141YSI IncorporatedYSI INCORPORATED15042016-09-26
00851683007172YSI IncorporatedYSI INCORPORATED23292016-09-26
00856522006040LA CartridgeLifehealth0787702016-09-24
00856522006071LA CartridgeLifehealth0787702016-09-24