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Panels › Clinical Chemistry › Product code CHI · Class 1

Lipase-Esterase, Enzymatic, Photometric, Lipase

Regulation 862.1465

0510(k)s in 12 months (20 all time)
0recalls in 12 months (22 all time)
9recalls that name a 510(k)
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Top companies in CHI

DateFirm and productCodeLinked 510(k)
Nov 6, 2023Ortho-Clinical Diagnostics, INc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Open, Classified
CHINone listed
Aug 4, 2020RANDOX LABORATORIES, LTD.
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Terminated
CHINone listed
Aug 4, 2020RANDOX LABORATORIES, LTD.
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Terminated
CHINone listed
Aug 4, 2020RANDOX LABORATORIES, LTD.
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Terminated
CHINone listed
Jan 30, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the
Terminated
CHINone listed
Feb 6, 2019Medica Corporation
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wa
Terminated
CHINone listed
Oct 30, 2018Horiba Instruments Incorporated
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Terminated
CHINone listed
Sep 7, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in huma
Terminated
CHIK952816
Sep 7, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and
Terminated
CHIK952816
Dec 14, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Terminated
CHINone listed
Nov 21, 2017Medica Corporation
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution i
Terminated
CHINone listed
Apr 20, 2015Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Terminated
CHINone listed
Oct 28, 2014Abbott Laboratories, Inc
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Terminated
CHINone listed
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) a
Terminated
CHINone listed
Dec 10, 2010Siemens Healthcare Diagnostics, Inc.
Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
Terminated
CHIK952816
Aug 22, 2008Genzyme Corporation
Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
Terminated
CHIK897150
Aug 22, 2008Genzyme Corporation
Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-D For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
Terminated
CHIK897150
Aug 22, 2008Genzyme Corporation
Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
Terminated
CHIK897150
Aug 22, 2008Genzyme Corporation
Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.
Terminated
CHIK897150
Sep 18, 2007Abbott Laboratories Inc.
Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
Terminated
CHINone listed
Dec 5, 2006Ortho-Clinical Diagnostics
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides p
Terminated
CHIK845027
Nov 30, 2004Beckman Coulter Inc
SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
Terminated
CHIK970905

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