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Panels › Clinical Chemistry › Product code JJY · Class 1

Multi-Analyte Controls, All Kinds (Assayed)

Regulation 862.1660

0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
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Top companies in JJY

DateFirm and productCodeLinked 510(k)
Jun 13, 2018Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
Terminated
JJYK972608
Jun 8, 2018Randox Laboratories Ltd.
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay
Terminated
JJYK110534
Mar 5, 2018Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
Terminated
JJYNone listed
Aug 11, 2017Randox Laboratories
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Terminated
JJYK140522
Aug 11, 2017Randox Laboratories
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Terminated
JJYK140522
Aug 8, 2017Randox Laboratories, Limited
Liquid Cardiac Control CQ5053
Terminated
JJYK110534
Jul 10, 2017Ortho Clinical Diagnostics Inc
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Us
Terminated
JJYK042006
May 31, 2017Roche Diagnostics Corporation
Elecsys PreciControl Varia 3
Terminated
JJYK111506
May 26, 2017Randox Laboratories
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
Terminated
JJYK110904
May 20, 2017Medtest Holdings, Inc.
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Terminated
JJYNone listed
Nov 16, 2016Alere San Diego, Inc.
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test p
Terminated
JJYK072892
Oct 14, 2016Helena Laboratories, Inc.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Terminated
JJYK821982
Oct 7, 2016Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_
Terminated
JJYK050374
Sep 16, 2016Randox Laboratories
The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T
Terminated
JJYK110534
Oct 15, 2015Alere San Diego, Inc.
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) an
Terminated
JJYK102700
Sep 15, 2015MedtestDx, Inc.
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled in
Terminated
JJYK942458
Dec 4, 2014Microgenics Corporation
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determin
Terminated
JJYK061196
Nov 13, 2014Siemens Healthcare Diagnostics, Inc.
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE Systems Analyzers for the quantitative measurement of calcito
Terminated
JJYK023304
Oct 23, 2014Medtest Holdings, Inc.
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 ce
Terminated
JJYK942458
Jun 26, 2014Microgenics Corporation
MAS Omni Immune PRO Controls
Terminated
JJYK110616
Jun 26, 2014Microgenics Corporation
MAS Omni Immune Controls
Terminated
JJYK110616
Feb 3, 2014Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and mater
Terminated
JJYK110137
K110530
Jan 31, 2014Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Terminated
JJYK052007
May 16, 2013Bio-rad Laboratories, Inc.
Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for t
Terminated
JJYK040822
Jan 29, 2013Alere San Diego, Inc.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the perform
Terminated
JJYK102700
Jan 29, 2013Alere San Diego, Inc.
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of
Terminated
JJYK102700
Nov 19, 2012Microgenics Corporation
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laborator
Terminated
JJYK110616
Jan 11, 2012Microgenics Corporation
ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-X
Terminated
JJYK061196
Feb 2, 2011Abbott Point of Care Inc.
i-STAT Level 2 Control Value Assignment Sheets Human Consumption
Terminated
JJYNone listed
Nov 22, 2010Biosite Inc Dba Innovacon Inc.
Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used for verifying the reportable range of tests on the Cholestech LDX System.
Terminated
JJYK913687
Nov 22, 2010Biosite Inc Dba Innovacon Inc.
Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control material for use with the Cholestech LDX System.
Terminated
JJYK913687
Nov 22, 2010Biosite Inc Dba Innovacon Inc.
Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. Assayed quality control material for use with the Cholestech LDX System.
Terminated
JJYK913687
Nov 22, 2010Biosite Inc Dba Innovacon Inc.
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713. Assayed quality control material for use with the Cholestech LDX System.
Terminated
JJYK913687
Nov 22, 2010Biosite Inc Dba Innovacon Inc.
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712. Assayed quality control material for use with the Cholestech LDX System.
Terminated
JJYK913687
Jun 11, 2010Biosite Inc
Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. Intended use: Materials used with the Triage Profiler S.O.
Terminated
JJYK072892
Jun 11, 2010Biosite Inc
Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test,
Terminated
JJYK072892
Jun 11, 2010Biosite Inc
Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Tes
Terminated
JJYK072892
Apr 6, 2010Vital Diagnostics, Inc.
ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Terminated
JJYK040273
Apr 6, 2010Vital Diagnostics, Inc.
Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Terminated
JJYK040273
Jan 17, 2009Quantimetrix Corporation
Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient c
Terminated
JJYK970862
Jan 17, 2009Quantimetrix Corporation
Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a m
Terminated
JJYK925256
Mar 4, 2008Roche Diagnostics Corp.
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
Terminated
JJYK060373
Dec 29, 2007Roche Diagnostics Corp.
Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roch
Terminated
JJYK031880
Dec 29, 2007Roche Diagnostics Corp.
Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog. No. 20752401190. Roche Diagnos
Terminated
JJYK031880
Jul 20, 2004Beckman Coulter Inc
Synchron Systems Hemoglobin A1c (HbA1c) Reagent
Terminated
JJYK974452

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