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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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EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020GV
In Commercial Distribution

  • 05391516748735 ()
44-2020GV

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Lyme Disease IgM IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100M
In Commercial Distribution

  • 05391516746199 ()
32-5100M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Lyme Disease IgG IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100G
In Commercial Distribution

  • 05391516746182 ()
32-5100G

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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
No Description
DIASORIN MOLECULAR LLC
EL0312
In Commercial Distribution

  • 10816101022042 ()
EL0312

  • West Nile virus immunoglobulin M (IgM) antibody IVD, control
  • West Nile virus immunoglobulin G (IgG) antibody IVD, control
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 International Inc
EIA-5297
In Commercial Distribution

  • 00840239052971 ()
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
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
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
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)
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
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)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-2005-4 G
Not in Commercial Distribution

  • 04049016089537 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1010-4 G
Not in Commercial Distribution

  • 04049016089520 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-4 G
Not in Commercial Distribution

  • 04049016089513 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
BAILEY LACHRYMAL CANNULA G w g reinforce
Avalign Technologies, Inc.
92-850
In Commercial Distribution

  • 00190776201395 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
G&G ROUNDED WEDGE 44X60 BUNDLE 12
Asp Global, LLC
GGTS12
In Commercial Distribution

  • 00840216120501 ()


  • Freestanding patient positioner, reusable
G&G ANGLED WEDGE BUNDLE BARIATRIC 14
Asp Global, LLC
GGTS14
In Commercial Distribution

  • 00840216121898 ()


  • Freestanding patient positioner, reusable
AXIOM CUSHION G
KI MOBILITY, LLC
G
In Commercial Distribution

  • 00850013379149 ()


  • Wheelchair seat cushion
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