Home GUDID 10758750004454 VITROS
Primary DI 10758750004454
Brand VITROS
Company ORTHO-CLINICAL DIAGNOSTICS, INC.
Model 8150112
Catalog number 8150112
Device description VITROS Chemistry Products LAC Slides
Published 2020-04-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KHP ACID, LACTIC, ENZYMATIC METHOD
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10758750004454 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10758750004454 10758750004454
GMDN Terms# Term, Definition table Term Definition Lactate IVD, reagent 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -18 Degrees Celsius -18 Degrees Celsius
Regulatory Flags# DUNS number 623873044 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816042014543 FORA FORA CARE INC. KHP 2025-05-06 80816042014549 FORA FORA CARE INC. KHP 2025-05-06 00850014861407 HeartsCare LACTATE TEST STRIPS (10PCS/BOX) Hearts Bio, Inc. KHP 2024-07-08 00850014861537 HeartsCare LACTATE TEST STRIPS (25PCS/BOX) Hearts Bio, Inc. KHP 2024-07-08 05700699460509 SC90 50 BG, LYT, MET, OXI + QC Radiometer Medical ApS KHP 2024-07-01 00380740158392 ARCHITECT ABBOTT IRELAND KHP 2024-01-24 00380740158408 Alinity ABBOTT IRELAND KHP 2024-01-24 00816042014505 FORA FORA CARE INC. KHP 2023-10-31 00850014861360 HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) Hearts Bio, Inc. KHP 2023-08-08 06971674866756 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 06971674866763 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 06971674866770 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 00630414610979 Atellica CH Lactate_3 Siemens Healthcare Diagnostics Inc. KHP 2023-05-10 10385480408131 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480408141 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480408158 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480626248 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 10054749005502 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00054749005505 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00630414606460 epoc Host2 Epocal Inc KHP 2020-07-15 00630414286143 RAPIDPoint® 500e Blood Gas System Siemens Healthcare Diagnostics Inc. KHP 2020-04-15 05700699441362 S8377 REF 944-136 *6 Cleaning solution Met II Solution Radiometer Medical ApS KHP 2018-09-21 05700699055903 Disposable Waste Container D512 REF 905-590 Radiometer Medical ApS KHP 2018-09-21 05700699058027 Disposable Waste Container D513 REF 905-802 Radiometer Medical ApS KHP 2018-09-21 05700699059178 REF 905-917 ABL90 FLEX sBOX Radiometer Medical ApS KHP 2018-09-21 05700699059185 905-918 ABL90 FLEX flush device Radiometer Medical ApS KHP 2018-09-21 05700699059567 REF 905-956 ABL90 FLEX sBOX PLUS Radiometer Medical ApS KHP 2018-09-21 05700699250476 925-047 ABL90 FLEX inlet clip Radiometer Medical ApS KHP 2018-09-21 05700699439062 S5362 REF 943-906 Radiometer Medical ApS KHP 2018-09-21 05700699441232 Cleaning Solution with additive S7375 REF 944-123 Radiometer Medical ApS KHP 2018-09-21