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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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The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is designed for the qualitative and semi-quantitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This Test System should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
FA9351GM
In Commercial Distribution

  • 00845533001656 ()
FA9351GM

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5297
In Commercial Distribution

  • 04048474052978 ()
EIA-5297

  • Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Each dropper bottle contains 2.7 ml of latex reagent for the detection of Legionella micdadei from culture plates.
PRO-LAB, INCORPORATED
PL.221
In Commercial Distribution

  • 10628429001810 ()
PL.221

  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
L. pneumophila serogroup 2
PRO-LAB, INCORPORATED
PL.210
In Commercial Distribution

  • 10628429001728 ()
PL.210

  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
An EIA assay for spotted fever Rickettsiosis IgG levels
FULLER LABORATORIES
N/A
In Commercial Distribution

  • B266SFG96K0 ()
SFG96K

  • Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
VZN-7010
In Commercial Distribution

  • B110VZN70100 ()
VZN-7010

  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
TSC Uni-Planar Screw 7.0 x 35mm
Seaspine, Inc.
70-7035
Not in Commercial Distribution

  • M5567070351 ()
  • 10381780006046 ()

  • 7.0 x 35mm
70-7035

  • Multiple Rickettsia species (typhus group) immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
MPN-1210
In Commercial Distribution

  • B110MPN12100 ()
MPN-1210

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control
No Description
AGFA
G Plus 35x92
In Commercial Distribution

  • 05414904221464 ()
  • 05414904016138 ()
  • 05414904221471 ()

  • Width: 92 Centimeter
  • Length: 35 Centimeter
EZQG7

  • Medical x-ray film, screen
Endodontic instrument for professionnal dental use only
MICRO MEGA
n014 3% L29 Classics Sterile
In Commercial Distribution

  • J015209482030 ()
  • J015209482031 ()
  • J015209482039 ()
20948203

  • Rotary/reciprocating endodontic file/rasp, single-use
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