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)
Top companies in LPS
| Company | 510(k)s | Recalls |
|---|---|---|
| Axis-Shield Diagnostics, Ltd. | 3 | 4 |
| Catch Incorporated | 2 | 2 |
| Diazyme Laboratories | 4 | 0 |
| Siemens Healthcare Diagnostics, Inc | 0 | 4 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 1 |
| Roche Diagnostics Operations, Inc. | 0 | 3 |
| Anticancer, Inc. | 2 | 0 |
| Axis Biochemicals, Asa | 2 | 0 |
| Bayer Diagnostics Corp. | 2 | 0 |
| Dade Behring, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2024 | Roche 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 |
LPS | K113793 |
| Oct 4, 2019 | Roche 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 |
LPS | K113793 |
| Sep 16, 2019 | Axis-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 |
LPS | K083222 |
| Sep 16, 2019 | Axis-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 |
LPS | K083222 |
| Sep 16, 2019 | Axis-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 |
LPS | K083222 |
| Nov 30, 2018 | Tosoh 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 |
LPS | K121533 |
| Jan 11, 2017 | Siemens 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 |
LPS | K052788 |
| May 17, 2016 | CSL 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 |
LPS | K063206 |
| Jul 1, 2015 | Axis-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 |
LPS | K083222 |
| May 15, 2015 | Roche 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 |
LPS | K113793 |
| Apr 3, 2015 | Medtest 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 |
LPS | K083222 |
| Jul 2, 2014 | Siemens 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 |
LPS | K013406 |
| Dec 19, 2013 | Siemens 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 |
LPS | K063206 |
| Jun 19, 2013 | Ortho-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 |
LPS | K061588 |
| Nov 6, 2012 | Siemens 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 |
LPS | K063206 |
| Jan 27, 2012 | Catch 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 |
LPS | None listed |
| Jan 6, 2009 | Catch 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 |
LPS | K011689 K011692 |
| Sep 11, 2003 | Abbott 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 |
LPS | K992858 |
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