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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BioPlex 2200 - 00847865012607

EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865011006

Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010986

BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865002240

ToRC IgG Assay Protocol File CD, SW 4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002240 ()

  • 1 Each
6651670G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ARCHITECT - 00380740152147

ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740152130

ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD

BOSS Instruments - 00888515228634

Sickle Knife, 7.5mm cd bld, 6 1/2"
BOSS INSTRUMENTS, LTD., INC.
90-3301
In Commercial Distribution

  • 00888515228634 ()
90-3301

  • Ear knife

ADULT LIMB RECONSTRUCTION SYSTEM - 18032568036404

CD UNIT FOR MICROMETRIC SWIVELLING CLAMP FOR LRS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568036404 ()
50112

  • External orthopaedic fixation system, reusable

ELBOW FIXATOR - 18032568030778

CD UNIT SPACERS (1 PAIR) FOR ELBOW FIXATOR
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568030778 ()
10076

  • External orthopaedic fixation system, reusable

ADVANCED LIMB RECONSTRUCTION SYSTEM - 18033509855665

ADV GARCHES CD UNIT STANDARD EXTENDS 5,5 CM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509855665 ()

  • Width: 116 Millimeter
53004

  • External orthopaedic fixation system, reusable
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