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Panels › Clinical Chemistry › Product code JIX · Class 2

Calibrator, Multi-Analyte Mixture

Regulation 862.1150

0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
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Top companies in JIX

DateFirm and productCodeLinked 510(k)
Aug 5, 2026Aniara Diagnostica LLC
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Open, Classified
JIXNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Open, Classified
JIXNone listed
May 3, 2024Randox Laboratories Ltd.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Open, Classified
JIXK053153
Mar 20, 2024Randox Laboratories Ltd.
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Open, Classified
JIXK061056
Jan 18, 2024Randox Laboratories Ltd.
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Open, Classified
JIXK053153
Jan 18, 2024Randox Laboratories Ltd.
Calibration Serum Level 3 CAL2351
Open, Classified
JIXK053153
Jan 18, 2024Randox Laboratories Ltd.
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Open, Classified
JIXK053153
Dec 21, 2023Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
Open, Classified
JIXK122398
Dec 21, 2023Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
Open, Classified
JIXK122398
Dec 21, 2023Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
Open, Classified
JIXK122398
Dec 21, 2023Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
Open, Classified
JIXK122398
Aug 23, 2023Randox Laboratories Ltd.
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferri
Open, Classified
JIXK061056
Mar 29, 2021Randox Laboratories Ltd.
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Terminated
JIXK053153
Feb 18, 2021Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Produ
Terminated
JIXNone listed
Nov 2, 2020Chromsystems Instruments & Chemicals GmbH
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in
Terminated
JIXNone listed
Oct 29, 2020Chromsystems Instruments & Chemicals GmbH
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Completed
JIXNone listed
Dec 16, 2019Ortho Clinical Diagnostics Inc
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL
Terminated
JIXNone listed
Nov 19, 2019Siemens Healthcare Diagnostics, Inc.
Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay
Terminated
JIXK081294
Nov 19, 2019Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP
Terminated
JIXK081294
Aug 9, 2019Randox Laboratories Ltd.
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Co
Terminated
JIXK061056
Jul 12, 2019Randox Laboratories Ltd.
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The c
Terminated
JIXK053153
Jul 8, 2019Ortho Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Terminated
JIXNone listed
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Terminated
JIXK063144
Jul 8, 2019Ortho Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Terminated
JIXNone listed
Nov 19, 2018Randox Laboratories Ltd.
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Terminated
JIXK031608
Jul 11, 2018Ortho-Clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in
Terminated
JIXK071801
Jun 5, 2018Tosoh Bioscience Inc
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) f
Terminated
JIXK111335
K121533 +2
Mar 26, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL),
Terminated
JIXK101460
Aug 24, 2017Beckman Coulter Inc.
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzer
Terminated
JIXK043460
Jul 19, 2017Kamiya Biomedical Company, LLC
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Al
Terminated
JIXK993853
Jul 13, 2017Beckman Coulter Inc
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
Terminated
JIXK071277
Apr 18, 2017ELITech Clinical Systems SAS
ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
Terminated
JIXK945271
Sep 15, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (G
Terminated
JIXK061838
May 5, 2016Siemens Healthcare Diagnostics, Inc.
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. F
Terminated
JIXK103612
Mar 8, 2016Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the followi
Terminated
JIXK932955
Mar 8, 2016Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays us
Terminated
JIXK932955
Mar 8, 2016Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays
Terminated
JIXK932955
Feb 29, 2016AMS Diagnostics, LLC
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte sys
Open, Classified
JIXNone listed
Mar 25, 2015Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry
Terminated
JIXK093732
Dec 16, 2014Siemens Healthcare Diagnostics, Inc
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Terminated
JIXK932955
Sep 30, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid
Terminated
JIXK061838
Sep 15, 2014Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in v
Terminated
JIXK081895
Aug 13, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN
Terminated
JIXK072443
Mar 5, 2014Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective el
Terminated
JIXK110530
Feb 25, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350
Terminated
JIXK081411
K922072
Feb 24, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate
Terminated
JIXK061923
May 17, 2013Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic System
Terminated
JIXK973030
Oct 22, 2012Beckman Coulter Inc.
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems
Terminated
JIXK110251
Mar 22, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITRO
Terminated
JIXK001679
K922072
Jan 27, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagno
Terminated
JIXK934071

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