FDA.reportPublic FDA data

Lactate IVD, kit, enzyme spectrophotometry

Definition
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.
GUDID devices
20
Last updated
2023-05-18 06:39:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414305066Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.115372182023-05-10
00811727015891Pointe Lactate Reagent HORIBA INSTRUMENTS INCORPORATED14-L7596-3802021-01-30
00811727016195Pointe Lactic Acid ReagentHORIBA INSTRUMENTS INCORPORATED16-L7596-4002021-01-30
04015630918911Lactate Gen.2Roche Diagnostics GmbH31837001902021-01-18
04015630925148Lactate Gen.2Roche Diagnostics GmbH51718811902021-01-18
04015630926954Lactate Gen.2Roche Diagnostics GmbH54016661902021-01-18
00842768005398Dimension® Flex® reagent cartridge LASiemens Healthcare Diagnostics Inc.104449612020-09-24
00842768015243Dimension Vista® Flex® reagent cartridge LASiemens Healthcare Diagnostics Inc.104451532020-09-24
03610230007068Yumizen C1200 LactateHORIBA ABX SAS 1300023854 2020-09-09
00630414287270Atellica CH Lactate_2 (Lac_2)Siemens Healthcare Diagnostics Inc.115325682020-08-19
07613336121351Lactate Gen.2Roche Diagnostics GmbH080579401902020-03-05
05055273204070L-LACTATE (LAC)RANDOX LABORATORIES LIMITEDLC23892019-06-03
05055273204094L-LACTATE (LAC)RANDOX LABORATORIES LIMITEDLC39802019-06-03
15099590010898AUBeckman Coulter, Inc.OSR61932016-09-24
00817439020963MedTest DX Lactate Medtest Dx, Inc.LAC4802016-09-30
00811727011664Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDL7596-502016-08-31
00811727014771Pointe Scientific, Inc. LDHORIBA INSTRUMENTS INCORPORATEDHL956-14002016-08-31
00811727015075Pointe Scientific, Inc. LactateHORIBA INSTRUMENTS INCORPORATEDOL956-2952016-08-31
00630414475660ADVIA® Chemistry LAC Lactate ReagentsSiemens Healthcare Diagnostics Inc.103257762016-09-24
00630414596280Atellica CH LacSiemens Healthcare Diagnostics Inc.110976142017-12-22