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)
Top companies in JIX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 Open, Classified |
JIX | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. Open, Classified |
JIX | None listed |
| May 3, 2024 | Randox 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 |
JIX | K053153 |
| Mar 20, 2024 | Randox 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 |
JIX | K061056 |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays
Catalog Number: CAL2351 Open, Classified |
JIX | K053153 |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3
CAL2351 Open, Classified |
JIX | K053153 |
| Jan 18, 2024 | Randox 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 |
JIX | K053153 |
| Dec 21, 2023 | Siemens 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 |
JIX | K122398 |
| Dec 21, 2023 | Siemens 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 |
JIX | K122398 |
| Dec 21, 2023 | Siemens 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 |
JIX | K122398 |
| Dec 21, 2023 | Siemens 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 |
JIX | K122398 |
| Aug 23, 2023 | Randox 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 |
JIX | K061056 |
| Mar 29, 2021 | Randox Laboratories Ltd. Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator.
Catalogue Number: CAL2351 Terminated |
JIX | K053153 |
| Feb 18, 2021 | Ortho-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 |
JIX | None listed |
| Nov 2, 2020 | Chromsystems 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 |
JIX | None listed |
| Oct 29, 2020 | Chromsystems 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 |
JIX | None listed |
| Dec 16, 2019 | Ortho 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 |
JIX | None listed |
| Nov 19, 2019 | Siemens 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 |
JIX | K081294 |
| Nov 19, 2019 | Siemens 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 |
JIX | K081294 |
| Aug 9, 2019 | Randox 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 |
JIX | K061056 |
| Jul 12, 2019 | Randox 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 |
JIX | K053153 |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer Terminated |
JIX | None listed |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Terminated |
JIX | K063144 |
| Jul 8, 2019 | Ortho Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer Terminated |
JIX | None listed |
| Nov 19, 2018 | Randox 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 |
JIX | K031608 |
| Jul 11, 2018 | Ortho-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 |
JIX | K071801 |
| Jun 5, 2018 | Tosoh 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 |
JIX | K111335 K121533 +2 |
| Mar 26, 2018 | Siemens 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 |
JIX | K101460 |
| Aug 24, 2017 | Beckman 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 |
JIX | K043460 |
| Jul 19, 2017 | Kamiya 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 |
JIX | K993853 |
| Jul 13, 2017 | Beckman 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 |
JIX | K071277 |
| Apr 18, 2017 | ELITech 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 |
JIX | K945271 |
| Sep 15, 2016 | Siemens 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 |
JIX | K061838 |
| May 5, 2016 | Siemens 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 |
JIX | K103612 |
| Mar 8, 2016 | Siemens 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 |
JIX | K932955 |
| Mar 8, 2016 | Siemens 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 |
JIX | K932955 |
| Mar 8, 2016 | Siemens 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 |
JIX | K932955 |
| Feb 29, 2016 | AMS 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 |
JIX | None listed |
| Mar 25, 2015 | Siemens 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 |
JIX | K093732 |
| Dec 16, 2014 | Siemens Healthcare Diagnostics, Inc Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) Terminated |
JIX | K932955 |
| Sep 30, 2014 | Siemens 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 |
JIX | K061838 |
| Sep 15, 2014 | Siemens 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 |
JIX | K081895 |
| Aug 13, 2014 | Ortho-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 |
JIX | K072443 |
| Mar 5, 2014 | Horiba 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 |
JIX | K110530 |
| Feb 25, 2014 | Ortho-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 |
JIX | K081411 K922072 |
| Feb 24, 2014 | Siemens 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 |
JIX | K061923 |
| May 17, 2013 | Ortho-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 |
JIX | K973030 |
| Oct 22, 2012 | Beckman 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 |
JIX | K110251 |
| Mar 22, 2012 | Ortho-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 |
JIX | K001679 K922072 |
| Jan 27, 2012 | Ortho-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 |
JIX | K934071 |
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