DAO

Product Code: DAO


Products Classified as DAO

2905Igm (mu Chain Specific), Antigen, Antiserum, ControlImmunoglobulin (light Chain Specific) Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2905Igm (mu Chain Specific), Antigen, Antiserum, ControlImmunoglobulin (light Chain Specific) Immunological Test System.

FDA Consensus Standards

Igm (Mu Chain Specific), Antigen, Antiserum, Control [14932]21 CFR §866.5550 🔎

Pre-market Notifications for DAO

K040431ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2ROCHE DIAGNOSTICS CORP.
K982639SPIFE URINE IFEHELENA LABORATORIES
K955908BOEHRINGER MANNHEIM IGM ASSAYBOEHRINGER MANNHEIM CORP.
K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MAPPLICATIONS LAB
K841992MODIFICATION TO ACS CORONARY GUIDINGADVANCED CARDIOVASCULAR SYSTEMS, INC.
K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAKO CORP.
K800450GEMENI IGM ASSAYELECTRO-NUCLEONICS LABORATORIES, INC.
K790705ANTISERUM TO HUMAN IGMKENT LABORATORIES, INC.

Global Unique Device Identification Database

05700572001416IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL
B1761030Igm (Mu Chain Specific), Antigen, Antiserum, Control
07613336121337IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL

Maude Adverse Events

IGM-2 TINA-QUANT IGM GEN.2ROCHE DIAGNOSTICS2018-04-24
IGM-2 TINA-QUANT IGM GEN.2ROCHE DIAGNOSTICS2017-01-25
TINA-QUANT IGM GEN.2ROCHE DIAGNOSTICS2016-03-16
IMMAGE? 800 IMMUNOCHEMISTRY SYSTEMBECKMAN COULTER, INC.2012-08-30
IMMAGE? 800 IMMUNOCHEMISTRY SYSTEMBECKMAN COULTER, INC.2012-08-30
TINA QUANT IGMROCHE - GMBH2002-02-21
TINA-QUANT IGMRD GMBH2001-09-05
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