DEW

Product Code: DEW


Products Classified as DEW

2963Igg, Antigen, Antiserum, ControlImmunoglobulins A, G, M, D, And E Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2963Igg, Antigen, Antiserum, ControlImmunoglobulins A, G, M, D, And E Immunological Test System.

FDA Consensus Standards

Igg, Antigen, Antiserum, Control [14932]21 CFR §866.5510 🔎

Pre-market Notifications for DEW

K050113TINA-QUANT IGG GEN.2ROCHE DIAGNOSTICS CORP.
K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2ROCHE DIAGNOSTICS CORP.
K993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWAKO CHEMICALS, USA, INC.
K993281K-ASSAY IGGKAMIYA BIOMEDICAL CO.
K983221IGGABBOTT LABORATORIES
K965108SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENTBECKMAN INSTRUMENTS, INC.
K963974IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULINBECKMAN INSTRUMENTS, INC.
K963868IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)BECKMAN INSTRUMENTS, INC.
K962202QUANTEX IGGINSTRUMENTATION LABORATORY CO.
K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORRANDOX LABORATORIES, LTD.
K951635BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROLBECKMAN INSTRUMENTS, INC.
K943997BEHRING NEPHELOMETER IIBEHRING DIAGNOSTICS, INC.
K934324OT IGG SORBENTORGANON TEKNIKA CORP.
K933314RADIAS FERRITIN ENZYME IMMUNOASSAYBIO-RAD
K924197ZORBA(TM) IGG REMOVAL REAGENTZEUS SCIENTIFIC, INC.

Global Unique Device Identification Database

00380740019761IGG, ANTIGEN, ANTISERUM, CONTROL
00816426020108Igg, Antigen, Antiserum, Control
00842768012174IGG, ANTIGEN, ANTISERUM, CONTROL
00842768012167IGG, ANTIGEN, ANTISERUM, CONTROL
05700572001386IGG, ANTIGEN, ANTISERUM, CONTROL
05700572000860IGG, ANTIGEN, ANTISERUM, CONTROL
05700572000273IGG, ANTIGEN, ANTISERUM, CONTROL
05055273203974Igg, Antigen, Antiserum, Control
05055273203950Igg, Antigen, Antiserum, Control
05055273203936Igg, Antigen, Antiserum, Control
05051700010948Igg, Antigen, Antiserum, Control
05051700010931Igg, Antigen, Antiserum, Control
05051700010924Igg, Antigen, Antiserum, Control
05051700010917Igg, Antigen, Antiserum, Control
05051700010443Igg, Antigen, Antiserum, Control

Maude Adverse Events

VIDAS? ANALYSERBIOMERIEUX ITALIA S.P.A.2020-03-26
VIDAS? ANALYSER - 99735BIOMERIEUX ITALIA S.P.A.2020-01-13
VIDAS? ANALYSER - 99735BIOMERIEUX ITALIA S.P.A.2020-01-13
VIDAS? ANALYSER - 99735BIOMERIEUX ITALIA S.P.A.2020-01-13
VIDAS? ANALYSER - 99735BIOMERIEUX ITALIA S.P.A.2020-01-13
VIDAS? ANALYSER - 99735BIOMERIEUX ITALIA S.P.A.2020-01-13
VIDAS? ANALYSER - 99735BIOMERIEUX ITALIA S.P.A.2020-01-13
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2020-01-03
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-11-21
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-11-21
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-11-21
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-11-21
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-10-22
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-10-22
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-10-22
VIDAS? ANALYZERBIOMERIEUX ITALIA S.P.A.2019-08-06
BN II SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-01-02
IGG-2 TINA-QUANT IGG GEN.2ROCHE DIAGNOSTICS2017-10-16
VIDAS? ANALYZERBIOMERIEUX ITALIA2017-08-29
VIDAS? ANALYZERBIOM?RIEUX ITALIA2017-08-08
VIDAS? ANALYZERBIOMERIEUX SA2017-05-01
VIDAS? ANALYZERBIOMERIEUX SA2017-05-01
VIDAS? ANALYZERBIOMERIEUX SA2017-05-01
VIDAS? ANALYZERBIOMERIEUX SA2017-05-01
VIDAS? ANALYZERBIOMERIEUX SA2017-05-01
VIDAS? ANALYZERBIOMERIEUX SA2017-05-01
VIDAS? ANALYZERBIOMERIEUX SA2017-04-28
IGG-2 TINA-QUANT IGG GEN.2ROCHE DIAGNOSTICS2017-03-13
VIDAS? ANALYZERBIOM?RIEUX SA2017-02-23
BN II SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-02-08
VIDAS ANALYZERBIOMERIEUX, S.A.2016-12-01
BN II SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2016-10-25
VIDAS? ANALYZERBIOM?RIEUX ITALIA2016-09-14
VIDAS ANALYZERBIOM?RIEUX ITALIA2016-08-29
VIDAS? ANALYZERBIOM?RIEUX ITALIA2016-08-29
VIDAS ANALYZERBIOM?RIEUX ITALIA2015-09-02
VIDAS ANALYZERBIOM?RIEUX ITALIA2015-07-29
COBAS 6000 E601 MODULEROCHE DIAGNOSTICS2011-10-04
SYNCHRON LX CLINICAL CHEMISTRY TEST SYSTEM CALIBRATOR 1BECKMAN COULTER, INC.2011-09-27
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN IIBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-30
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN IIBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-03
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN IIBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-08-03
SYNCHRON CALIBRATOR 1BECKMAN COULTER INC.2011-06-10
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN IIBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-05-17
ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL)BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-05-09
ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)BIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-19
ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONORBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-19
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREENBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-15
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREENBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-12
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREENBIO-RAD MEDICAL DIAGNOSTICS GMBH2011-04-12
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