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Panels › Clinical Chemistry › Product code JJX · Class 1

Single (Specified) Analyte Controls (Assayed And Unassayed)

Regulation 862.1660

0510(k)s in 12 months (493 all time)
0recalls in 12 months (42 all time)
32recalls that name a 510(k)
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Top companies in JJX

DateFirm and productCodeLinked 510(k)
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Open, Classified
JJXNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Open, Classified
JJXNone listed
Jun 4, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS
Open, Classified
JJXNone listed
Mar 19, 2024Mckesson Medical-Surgical Inc. Corporate Office
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Open, Classified
JJXK050328
Jul 21, 2023Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the
Open, Classified
JJXNone listed
Feb 21, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siem
Open, Classified
JJXK010050
Feb 21, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
Open, Classified
JJXK010050
Feb 21, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
Open, Classified
JJXK010050
Oct 15, 2021Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Int
Terminated
JJXK032993
Apr 30, 2021Sentinel CH SpA
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Open, Classified
JJXNone listed
Jan 15, 2021Medline Industries Inc
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only.
Terminated
JJXNone listed
Sep 14, 2020Tosoh Bioscience Inc
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ON
Terminated
JJXNone listed
Apr 1, 2020Abbott Laboratories
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Terminated
JJXNone listed
May 24, 2019Abbott Laboratories
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, ca
Terminated
JJXK060964
Apr 9, 2019Abbott Laboratories
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human
Terminated
JJXK063232
Dec 3, 2018Randox Laboratories Ltd.
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Open, Classified
JJXK023763
Dec 3, 2018Randox Laboratories Ltd.
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Open, Classified
JJXK023763
Jan 10, 2017Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Terminated
JJXK961510
Jan 10, 2017Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Terminated
JJXK961510
Jan 10, 2017Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Terminated
JJXK961510
Nov 7, 2016Helena Laboratories, Inc.
Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 0018
Terminated
JJXK895528
Oct 24, 2016Beckman Coulter Inc.
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Terminated
JJXK994278
Nov 23, 2015Biochemical Diagnostics Inc
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures a
Terminated
JJXK050328
Aug 29, 2015Bayer Healthcare, LLC
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples
Terminated
JJXK111268
Jun 25, 2015Bio-Rad Laboratories, Inc.
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in
Terminated
JJXNone listed
Oct 24, 2014Abbott Laboratories
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to ly
Terminated
JJXK130255
May 29, 2014Abbott Laboratories
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300
Terminated
JJXK063232
Jun 21, 2013Microgenics Corporation
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a cons
Terminated
JJXK031890
Apr 17, 2013Lifescan Inc
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Terminated
JJXK072543
Apr 17, 2013Lifescan Inc
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
Terminated
JJXK062195
Mar 21, 2012Beckman Coulter Inc.
Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Terminated
JJXK994277
Jun 21, 2011Beckman Coulter Inc.
Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.
Terminated
JJXK994277
Apr 1, 2011Abbott Point Of Care Inc.
Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.
Terminated
JJXK031873
Apr 1, 2011Abbott Point Of Care Inc.
Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to ver
Terminated
JJXK031873
Aug 11, 2010Beckman Coulter Inc.
Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprote
Terminated
JJXK981864
Nov 13, 2008Abbott Laboratories
Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. A
Terminated
JJXK984323
Jul 31, 2008Abbott Laboratories
Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05 Intended for use in the verification of sensitivity, calibration linearity, and reportable r
Terminated
JJXK984074
Jul 31, 2008Abbott Laboratories
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and reportable r
Terminated
JJXK984070
Jan 19, 2008AmniSure International LLC
AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
Terminated
JJXK030849
Oct 3, 2007Tosoh Bioscience Inc
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Terminated
JJXNone listed
Sep 18, 2007Abbott Laboratories
ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and
Terminated
JJXK984324
Mar 15, 2006Abbott Diabetes Care, Inc.
FreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; Part Number: CAT70676-01
Terminated
JJXK013147

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