QA LATEX SHIMA (D-DIMER)

Company Name SHIMA LABORATORIES CO., LTD.
Address 1-16-4, MAENO-CHO
City, State / Province, ZIP / Postal Code ITABASHI-KU, TOKYO,
Country JA
FDA Owner/Operator Phone --
FDA Medical Specialty Code HE - Hematology
FDA Product Code DAP
FDA Classification Name FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code Standards
FDA Regulation Number 864.7320
FDA Common Generic Name D-DIMER ASSAY & CALIBRATOR
FDA Proprietary Device Name QA LATEX SHIMA (D-DIMER)
FDA Owner / Operator Number 9055348
FDA Owner / Operator Name SHIMA LABORATORIES CO., LTD.
FDA Establishment Registration Number 3003985394
FDA Registered Establishment Name SHIMA LABORATORIES CO., LTD.
FDA Operation Code(s) MM - Manufacturer

Competitors of SHIMA LABORATORIES CO., LTD.

Our records indicate that the following medical device companies may manufacture a similar device.

  Company Name Proprietary Device Name Common Generic Device Name
1 AMERICAN DIAGNOSTICA, INC. MULTIPLE VARIOUS
2 BECKMAN COULTER, INC. ACCESS D-DIMER REAGENT FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY
3 BIOKIT S.A. MULTIPLE D-DIMER CONTROLS
4 BIOMERIEUX SA VIDAS D DIMER (DD) ASSAY ENZYME-LINKED FLURESCENT IMMUNOASSAY (ELFA) FOR THE DETECTION OF D. DIMER
5 BIOMERIEUX, INC. VIDAS D DIMER (DD) ASSAY ENZYME-LINKED FLURESCENT IMMUNOASSAY (ELFA) FOR THE DETECTION OF D. DIMER
6 BIOSITE INCORPORATED TRIAGE PROFILER S.O.B. PANEL FLUORESCENCE IMMUNOASSAY FOR CKMB,TNL,MYOGLOBIN,ONP & D-DIMER
7 DADE BEHRING MARBURG GMBH MULTIPLE DETERMINATION OF FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, D-DIMER
8 DADE BEHRING, INC. D-DIMER CAL D-DIMER CAL
9 DIAGNOSTICA STAGO MULTIPLE VARIOUS
10 DIAGNOSTICA-STAGO MULTIPLE VARIOUS
11 FISHER DIAGNOSTICS PACIFIC HEMOSTASIS THROMBOSCREEN FDP ASSAY SET FIBRINOGEN DEGRADATION PRODUCTS ASSAY
12 KAMIYA BIOMEDICAL CO. K-ASSAY D-DIMER ASSAY, CALIBRATOR, CALIBRATOR DILUENT D-DIMER ASSAY, CALIBRATOR, CALIBRATOR DILUENT
13 KENT LABORATORIES, INC. ANTI HUMAN FIBRINOGEN & FIBRIN ANTISERUM
14 MORE DIAGNOSTICS FIBRIN (OGEN) FDP CONTROL MULTI-LEVEL FIBRINOGEN FDP CONTROLS
15 REMEL EUROPE LTD MULTIPLE FIBRIN/FIBRINOGEN DEGRADATION PRODUCTS
16 TRINITY BIOTECH, PLC MDA D-DIMER MDA D-DIMER


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