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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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CLIAWAIVED INC - 00183278000436

CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)
Cliawaived, Inc.
CLIA-INGM-MC42
In Commercial Distribution

  • 00183278000436 ()
CLIA-INGM-MC42

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
  • SARS-CoV-1 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical

Trinity Biotech - 05391516746199

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

Trinity Biotech - 05391516746182

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

Trinity Biotech - 05391516748742

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

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748735

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

IFA B. burgdorferi IgG/IgM Test System - 00845533001656

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

Rickettsia IgG ELISA - 00840239052971

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)

West Nile Virus DxSelect™ Negative Control - 10816101022042

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

Rickettsia IgG ELISA - 04048474052978

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)

IFA: Legionella Mosaic 4 (IgG) - 04049016089537

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

IFA: Legionella Mosaic 4 (IgG) - 04049016089520

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

IFA: Legionella Mosaic 4 (IgG) - 04049016089513

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

Varicella Zoster Negative Control - B110VZN70100

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

Mycoplasma pneumoniae Negative Control - B110MPN12100

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

Malibu - 10381780006046

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

Spotted Fever Rickettsia IgG ELISA Kit - B266SFG96K0

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)

Legionella micdadei DFA Reagent - 10628429001728

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

Prolex Legionella micdadei - 10628429001810

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

G Plus - 05414904016138

No Description
AGFA
G Plus 35x92
In Commercial Distribution

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

  • Width: 92 Centimeter
  • Length: 35 Centimeter
EZQG7

  • Medical x-ray film, screen

cardiofax G - 00841983102400

Cardiofax G Hospital Electrocardiograph
NIHON KOHDEN AMERICA, INC.
ECG-2550
Not in Commercial Distribution

  • 00841983102400 ()
ECG-2550A

  • Electrocardiograph, professional, multichannel

One G - J015209482031

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

One G - J015209482021

Endodontic instrument for professionnal dental use only
MICRO MEGA
n014 3% L25 Classics Sterile
In Commercial Distribution

  • J015209482029 ()
  • J015209482020 ()
  • J015209482021 ()
20948202

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

One G - J015209482011

Endodontic instrument for professionnal dental use only
MICRO MEGA
n014 3% L21 Classics Sterile
In Commercial Distribution

  • J015209482010 ()
  • J015209482011 ()
  • J015209482019 ()
20948201

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

AXIOM G - 00850013379149

AXIOM CUSHION G
KI MOBILITY, LLC
G
In Commercial Distribution

  • 00850013379149 ()


  • Wheelchair seat cushion

CryotopUS-scoop(G) - 04582231462841

Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
KITAZATO CORPORATION
CryotopUS-scoop(G)
In Commercial Distribution

  • 14582231462848 ()
  • 04582231462841 ()
81195

  • Assisted reproduction vitrification carrier

CryotopUS-flash(G) - 04582231462797

Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
KITAZATO CORPORATION
CryotopUS-flash(G)
In Commercial Distribution

  • 14582231462794 ()
  • 04582231462797 ()
81181

  • Assisted reproduction vitrification carrier

CryotopUS(G) - 04582231462476

No Description
KITAZATO CORPORATION
CryotopUS(G)
In Commercial Distribution

  • 14582231462473 ()
  • 04582231462476 ()
  • 14582231462527 ()


  • Assisted reproduction vitrification carrier

CryotopCL(G) - 04582231461950

No Description
KITAZATO CORPORATION
CryotopCL(G)
In Commercial Distribution

  • 14582231461957 ()
  • 04582231461950 ()


  • Assisted reproduction vitrification carrier

CryotopSC(G) - 04582231461905

No Description
KITAZATO CORPORATION
CryotopSC(G)
In Commercial Distribution

  • 14582231461902 ()
  • 04582231461905 ()


  • Assisted reproduction vitrification carrier

G/K - 04546540143471

K-Wire
Stryker GmbH
0152-0218
In Commercial Distribution

  • 04546540143471 ()

  • Length: 310.0 Millimeter
  • Diameter: 1.8 Millimeter
0152-0218

  • Orthopaedic guidewire, reusable
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