JIS

Product Code: JIS


Products Classified as JIS

443Calibrator, PrimaryCalibrator.

Total Product Life Cycle (TPLC) Devices

443Calibrator, PrimaryCalibrator.

FDA Consensus Standards

Calibrator, Primary [11559]21 CFR §862.1150 🔎

Pre-market Notifications for JIS

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRANDOX LABORATORIES LIMITED
K061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDADE BEHRING, INC.
K060266DIMENSION IRON CALIBRATORDADE BEHRING, INC.
K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDADE BEHRING, INC.
K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)DADE BEHRING, INC.
K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB
K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSOrtho-Clinical Diagnostics, Inc.
K030964CALIBRATION PLASMA LMW HEPARININSTRUMENTATION LABORATORY CO.
K030546CRP (II) CALIBRATORSDENKA SEIKEN CO., LTD.
K030320WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SETWAKO CHEMICALS, USA, INC.
K022901VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORSORTHO-CLINICAL DIAGNOSTICS
K022682RANDOX C-REACTIVE PROTEIN CALIBRATORRANDOX LABORATORIES, LTD.
K013126N LP(A) STANDARD SYDADE BEHRING, INC.
K012878THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609THERMO DMA, INC.
K011568RANDOX LIPOPROTEINRANDOX LABORATORIES, LTD.

Global Unique Device Identification Database

00380740135188Calibrator, primary
00380740011161CALIBRATOR, PRIMARY
00380740010492CALIBRATOR, PRIMARY
00380740010461CALIBRATOR, PRIMARY
00380740010447CALIBRATOR, PRIMARY
00380740003647CALIBRATOR, PRIMARY
00380740003630CALIBRATOR, PRIMARY
00380740003302CALIBRATOR, PRIMARY
00380740003272CALIBRATOR, PRIMARY
00380740003258CALIBRATOR, PRIMARY
00380740003227CALIBRATOR, PRIMARY
00630414598406Calibrator, primary
00630414598390Calibrator, primary
00630414598253Calibrator, primary
00630414597454Calibrator, primary

Maude Adverse Events

VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSORTHO-CLINICAL DIAGNOSTICS2020-03-10
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSORTHO-CLINICAL DIAGNOSTICS2019-10-24
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSORTHO-CLINICAL DIAGNOSTICS2018-02-25
ELECSYS HCG+? CALSETROCHE DIAGNOSTICS2017-11-20
ADVIA CENTAUR XP CALIBRATOR ESIEMENS HEALTHCARE DIAGNOSTICS, INC.2016-01-08
ADVIA CENTAUR XP CALIBRATOR ESIEMENS HEALTHCARE DIAGNOSTICS, INC.2015-12-15
COBAS E-ELECSYS ESTRADIOL GEN.2ROCHE DIAGNOSTICS2013-02-19
SYNCHRON SYSTEMS LIPID CALIBRATORBECKMAN COULTER, INC.2012-06-26
TOTAL AND DIRECT BILIRUBIN CALIBRATORBECKMAN COULTER, INC.2012-04-15
TOTAL AND DIRECT BILIRUBIN CALIBRATORBECKMAN COULTER, INC.2012-03-23
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBECKMAN COULTER INC.2012-03-05
SYNCHRON SYSTEMS CX C-REACTIVE PROTEIN (C-RP) CALIBRATORBECKMAN COULTER, INC.2012-01-03
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) CALIBRATORBECKMAN COULTER INC.2011-12-20
SYNCHRON? CX C-RP CALIBRATORBECKMAN COULTER INC.2011-12-19
ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBECKMAN COULTER INC.2011-07-30
ACCESS? OSTASE CALIBRATORBECKMAN COULTER, INC.2011-02-14
ACCESS? OSTASE CALIBRATORBECKMAN COULTER, INC.2011-02-09
CX TOTAL/DIRECT BILIRUBIN CALIBRATORBECKMAN COULTER INC.2010-12-20
IMX B12 CALIBRATORABBOTT HEALTH PRODUCTS, INC.1997-06-16
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