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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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Kalazar Detect Rapid Test for Visceral Leishmaniasis - B379INS0251

No Description
INBIOS INTERNATIONAL, INC
INS025
In Commercial Distribution

  • B379INS0251 ()
INS025

  • Leishmania donovani immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Chagas Detect™ Plus Rapid Test - B379CP0501

No Description
INBIOS INTERNATIONAL, INC
CP050
In Commercial Distribution

  • B379CP0501 ()
CP050

  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

NexGen® - 00889024208582

No Description
Zimmer, Inc.
5955-17-05
In Commercial Distribution

  • 00889024208582 ()

  • Size G Minus (G-)
00-5955-017-05

  • Knee femur prosthesis trial, reusable

NexGen® - 00889024208599

No Description
Zimmer, Inc.
5955-17-06
In Commercial Distribution

  • 00889024208599 ()

  • Size G Minus (G-)
00-5955-017-06

  • Knee femur prosthesis trial, reusable

NexGen® Gender Solutions® - 00889024191785

No Description
Zimmer, Inc.
00-5755-017-06
In Commercial Distribution

  • 00889024191785 ()

  • Size G Minus (G-)
00-5755-017-06

  • Knee femur prosthesis trial, reusable

NexGen® Gender Solutions® - 00889024191778

No Description
Zimmer, Inc.
00-5755-017-05
In Commercial Distribution

  • 00889024191778 ()

  • Size G Minus (G-)
00-5755-017-05

  • Knee femur prosthesis trial, reusable

Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set - 10673486002447

Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to streptococcal exoenzymes in human serum.
TECO DIAGNOSTICS
ASO-100
In Commercial Distribution

  • 10673486002447 ()
ASO-100

  • Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical

VIROTROL - 00847661005575

VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128B
In Commercial Distribution

  • 00847661005575 ()
00128B

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control

VIROTROL - 00847661005568

VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128A
In Commercial Distribution

  • 00847661005568 ()
00128A

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control

VIROCLEAR - 00847661002727

VIROCLEAR EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00131
In Commercial Distribution

  • 00847661002727 ()
00131

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
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