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Panels › Clinical Chemistry › Product code LPS · Class 2

Urinary Homocystine (Nonquantitative) Test System

Regulation 862.1377

0510(k)s in 12 months (29 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
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Top companies in LPS

DateFirm and productCodeLinked 510(k)
Nov 19, 2024Roche Diagnostics Operations, Inc.
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Open, Classified
LPSK113793
Oct 4, 2019Roche Diagnostics Operations, Inc.
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage:
Terminated
LPSK113793
Sep 16, 2019Axis-Shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocystein
Open, Classified
LPSK083222
Sep 16, 2019Axis-Shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteine
Open, Classified
LPSK083222
Sep 16, 2019Axis-Shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinem
Open, Classified
LPSK083222
Nov 30, 2018Tosoh Bioscience Inc
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Anal
Terminated
LPSK121533
Jan 11, 2017Siemens Healthcare Diagnostics, Inc.
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized pl
Terminated
LPSK052788
May 17, 2016CSL Behring GmbH
Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, hepariniz
Terminated
LPSK063206
Jul 1, 2015Axis-Shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on th
Terminated
LPSK083222
May 15, 2015Roche Diagnostics Operations, Inc.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of tot
Terminated
LPSK113793
Apr 3, 2015Medtest Holdings, Inc.
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of ca
Terminated
LPSK083222
Jul 2, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP
Terminated
LPSK013406
Dec 19, 2013Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma an
Terminated
LPSK063206
Jun 19, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Terminated
LPSK061588
Nov 6, 2012Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma,
Terminated
LPSK063206
Jan 27, 2012Catch Incorporated
Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in
Terminated
LPSNone listed
Jan 6, 2009Catch Incorporated
Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGEN
Terminated
LPSK011689
K011692
Sep 11, 2003Abbott Laboratories HPD/ADD/GPRD
AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
Terminated
LPSK992858

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