FDA Product Code LPS: Urinary Homocystine (nonquantitative) Test System
Leading manufacturers include Diazyme Laboratories, Dade Behring, Inc. and Ortho-Clinical Diagnostics, Inc..
29
Total
29
Cleared
109d
Avg days
1998
Since
FDA 510(k) Cleared Urinary Homocystine (nonquantitative) Test System Devices (Product Code LPS)
29 devices
Cleared
May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
Ortho-Clinical Diagnostics, Inc.
Chemistry
146d
Cleared
Jul 31, 2012
DIAZYME HOMOCYSTEINE POC TEST KIT
Diazyme Laboratories
Chemistry
116d
Cleared
Sep 17, 2007
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
Diazyme Laboratories
Chemistry
62d
Cleared
Apr 11, 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
Teco Diagnostics
Chemistry
119d
Cleared
Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
Chemistry
66d
Cleared
Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
Instrumentation Laboratory CO
Chemistry
106d
Cleared
Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
Ortho-Clinical Diagnostics, Inc.
Chemistry
43d
Cleared
Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
Diazyme Laboratories
Chemistry
35d
Cleared
Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
Dade Behring, Inc.
Chemistry
177d
Cleared
Sep 03, 2003
HOMOCYSTEINE MICROTITER PLATE ASSAY
Diazyme Laboratories
Chemistry
65d
Cleared
Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
Diagnostic Products Corp.
Toxicology
76d
Cleared
Dec 21, 1999
BIO-RAD HOMOCYSTEINE BY HPLC
Bio-Rad
Toxicology
95d
Cleared
Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
Abbott Laboratories
Chemistry
61d