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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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Remel - 00848838027093

Xpect C. diff Toxin A/B KT/20TST
REMEL, INC.
R24650
In Commercial Distribution

  • 30848838027094 ()
  • 00848838027093 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

ABBOTT PRISM - 00380740039219

ABBOTT PRISM Positive Run Control Kit
ABBOTT LABORATORIES
3E60-11
Not in Commercial Distribution

  • 00380740039219 ()
03E6011

  • Multiple blood-borne virus antigen/antibody IVD, control

ABBOTT PRISM - 00380740038403

ABBOTT PRISM Run Control Kit
ABBOTT LABORATORIES
3E60-10
Not in Commercial Distribution

  • 00380740038403 ()
03E6010

  • Multiple blood-borne virus antigen/antibody IVD, control

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124887

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-1601-8 G
In Commercial Distribution

  • 04049016124887 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124894

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-6401-8 G
In Commercial Distribution

  • 04049016124894 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369236

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369236 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369229

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369229 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

VIROTROL - 03610520530146

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000539
In Commercial Distribution

  • 03610520530146 ()
12000539

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 03610520530139

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000538
In Commercial Distribution

  • 03610520530139 ()
12000538

  • Multiple blood-borne virus antigen/antibody IVD, control

Status™ COVID-19/Flu Control - 10743816001614

Status™ COVID-19/Flu A&B Control Swab Kit (5 Positive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-511C-00
In Commercial Distribution

  • 10743816001614 ()
BSP-511C-00

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • Influenza A/B virus antigen IVD, control
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