Panels › Clinical Chemistry › Product code JIS · Class 2
Calibrator, Primary
Regulation 862.1150
0510(k)s in 12 months (130 all time)
0recalls in 12 months (21 all time)
15recalls that name a 510(k)
Top companies in JIS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. Open, Classified |
JIS | K013406 |
| May 27, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 Open, Classified |
JIS | None listed |
| May 14, 2024 | QUIDELORTHO VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or hepari Open, Classified |
JIS | K994145 |
| Mar 8, 2022 | Abbott Laboratories ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01
The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitativ Open, Classified |
JIS | K042924 |
| Jul 29, 2021 | Sentinel CH SpA Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], o Terminated |
JIS | None listed |
| Dec 22, 2020 | Fujifilm Medical Systems U.S.A., Inc. Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein Terminated |
JIS | K001005 |
| Nov 29, 2018 | Ortho Clinical Diagnostics Inc Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Sy Terminated |
JIS | K033300 |
| Mar 15, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture
Product Usage:
Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c Terminated |
JIS | K103836 |
| Oct 24, 2016 | Beckman Coulter Inc. Access Ostase Calibrators, Catalog No. 37305, B83876
Product Usage:
The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline Terminated |
JIS | K994278 |
| Aug 14, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF).
For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3 Terminated |
JIS | K961510 |
| Apr 15, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911.
For use in the quantitative determination of Vit D. Terminated |
JIS | None listed |
| Apr 15, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589.
For use in the quantitative determination of Vit D. Terminated |
JIS | None listed |
| Jan 29, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010.
The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dime Terminated |
JIS | K060266 |
| Dec 22, 2012 | Beckman Coulter Inc. Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805.
The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total t Terminated |
JIS | K023369 |
| Jun 21, 2011 | Beckman Coulter Inc. Access Immunoassay Systems
Ostase Calibrators, Part Number: 37305
The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosp Terminated |
JIS | K994278 |
| Jul 24, 2008 | Abbott Diagnostic International, Ltd. AxSYM Ultrasensitive hTSH II Master Calibrators
Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma. Terminated |
JIS | K952148 |
| Oct 28, 2006 | Tosoh Bioscience Inc TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box. Terminated |
JIS | K992365 |
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use. Terminated |
JIS | K935612 |
| Jul 23, 2004 | Beckman Coulter Inc Synchron Systems Lipid Calibrator (HDLD)
Part 650218 Terminated |
JIS | K983640 |
| Jul 23, 2004 | Beckman Coulter Inc Synchron Systems Prealbumin Reagent
Part Number: 475106 Terminated |
JIS | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Synchron CX (and) Synchron LX Systems Microalbumin Calibrator. Terminated |
JIS | None listed |
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