Home GUDID 15099590010898 AU
Primary DI 15099590010898
Brand AU
Company Beckman Coulter, Inc.
Model OSR6193
Device description Lactate
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use 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 15099590010898 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15099590010898 15099590010898
GMDN Terms# Term, Definition table Term Definition Lactate IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen, using an enzyme spectrophotometry method.
Regulatory Flags# DUNS number 008254708 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 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 00630414305066 Atellica CH Lactate_3 Siemens Healthcare Diagnostics Inc. KHP 2023-05-10 04015630918911 Lactate Gen.2 Roche Diagnostics GmbH KHP 2021-01-18 04015630925148 Lactate Gen.2 Roche Diagnostics GmbH KHP 2021-01-18 04015630926954 Lactate Gen.2 Roche Diagnostics GmbH KHP 2021-01-18 04713648766530 THE EDGE Blood Lactate Monitoring System APEX BIOTECHNOLOGY CORP. KHP 2021-01-18 04713648766547 THE EDGE Blood Lactate Test Strip (non-sterile) APEX BIOTECHNOLOGY CORP. KHP 2021-01-18 04713648766554 THE EDGE Lactate Control Solution APEX BIOTECHNOLOGY CORP. KHP 2021-01-18 00054749005505 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00842768005398 Dimension® Flex® reagent cartridge LA Siemens Healthcare Diagnostics Inc. KHP 2020-09-24 00842768015243 Dimension Vista® Flex® reagent cartridge LA Siemens Healthcare Diagnostics Inc. KHP 2020-09-24 03610230007068 Yumizen C1200 Lactate HORIBA ABX SAS KHP 2020-09-09 00380740179199 Alinity Abbott GmbH KHP 2020-08-28 00630414287270 Atellica CH Lactate_2 (Lac_2) Siemens Healthcare Diagnostics Inc. KHP 2020-08-19 00630414606095 epoc NXS Host Epocal Inc KHP 2020-06-18 10758750004454 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. KHP 2020-04-18 10758750004911 VITROS ORTHO-CLINICAL DIAGNOSTICS, INC. KHP 2020-04-18 07613336121351 Lactate Gen.2 Roche Diagnostics GmbH KHP 2020-03-05 05055273204070 L-LACTATE (LAC) RANDOX LABORATORIES LIMITED KHP 2019-06-03 05055273204094 L-LACTATE (LAC) RANDOX LABORATORIES LIMITED KHP 2019-06-03 05700699440570 S4970 Rinse 1 Solution for 600mL, for ABL7xx Radiometer Medical ApS KHP 2018-09-21