ClearanceBrief
Panels › Clinical Chemistry › Product code JIT · Class 2

Calibrator, Secondary

Regulation 862.1150

0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
Get daily alerts for JITSample briefCSV

Top companies in JIT

DateFirm and productCodeLinked 510(k)
Aug 5, 2026Aniara Diagnostica LLC
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Open, Classified
JITNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Open, Classified
JITNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Open, Classified
JITNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
Open, Classified
JITNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Open, Classified
JITNone listed
Apr 17, 2024Randox Laboratories Ltd.
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Open, Classified
JITNone listed
Jan 11, 2024Ortho-Clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
Open, Classified
JITK123343
Aug 24, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Open, Classified
JITNone listed
Jul 11, 2023Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT
Open, Classified
JITNone listed
Oct 13, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens M
Open, Classified
JITK131307
Oct 13, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Sieme
Open, Classified
JITK131307
Sep 14, 2020Tosoh Bioscience Inc
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the
Terminated
JITNone listed
Apr 1, 2020Abbott Laboratories
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Terminated
JITNone listed
May 24, 2019Abbott Laboratories
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide
Terminated
JITK060964
May 22, 2019Abbott Laboratories
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Terminated
JITK140654
Apr 9, 2019Abbott Laboratories
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of th
Terminated
JITNone listed
Apr 9, 2019Abbott Laboratories
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic an
Terminated
JITNone listed
Apr 9, 2019Abbott Laboratories
ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analyt
Terminated
JITNone listed
Apr 9, 2019Abbott Laboratories
ARCHITECT Intact PTH Calibrators - 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 hu
Terminated
JITK063232
Apr 9, 2019Abbott Laboratories
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (H
Terminated
JITK121842
Apr 9, 2019Abbott Laboratories
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human
Terminated
JITK070822
Dec 3, 2018Randox Laboratories Ltd.
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Open, Classified
JITK023763
Sep 26, 2018Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in v
Terminated
JITK161954
Sep 26, 2018Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro d
Terminated
JITK151767
Sep 26, 2018Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JITK151792
Sep 26, 2018Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro di
Terminated
JITK151792
Mar 5, 2018Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
Terminated
JITK100304
Apr 19, 2017Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Terminated
JITK021535
Apr 11, 2017Medica Corporation
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Terminated
JITK120497
Jan 5, 2017Ortho-Clinical Diagnostics
VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integr
Terminated
JITK041799
Jul 25, 2016Tosoh Bioscience, Inc.
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU re
Terminated
JITK153417
May 5, 2016Siemens Healthcare Diagnostics, Inc.
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only.
Terminated
JITK103836
Apr 19, 2016Ortho-Clinical Diagnostics
The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (
Terminated
JITK142595
Nov 2, 2015Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products C
Terminated
JITK081543
K941142
Jan 8, 2015Siemens Healthcare Diagnostics, Inc.
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
Terminated
JITK053576
Oct 6, 2014Siemens Healthcare Diagnostics, Inc.
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Terminated
JITK051087
Jun 26, 2014Siemens Healthcare Diagnostics, Inc.
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Di
Terminated
JITK081683
Jun 16, 2014Ortho-Clinical Diagnostics
VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VI
Terminated
JITK041799
May 29, 2014Abbott Laboratories
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in
Terminated
JITK063232
Mar 12, 2014Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP,
Terminated
JITK121608
Aug 7, 2013Siemens Healthcare Diagnostics, Inc.
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase M
Terminated
JITK970336
Jun 6, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Terminated
JITK020217
Jun 6, 2013Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Terminated
JITK020217
Mar 25, 2013Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Terminated
JITK061818
Oct 10, 2012Beckman Coulter Inc.
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Terminated
JITK111952
Oct 10, 2012Immunodiagnostics Systems Ltd
IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Contro
Terminated
JITNone listed
Mar 20, 2012Beckman Coulter Inc.
Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is
Terminated
JITK883181
Feb 7, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used t
Terminated
JITK042643
Jan 11, 2012Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
Terminated
JITK081683
May 20, 2011Beckman Coulter Inc.
SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibratio
Terminated
JITK965108

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.