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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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Spirochete - 00847627001542

No Description
BIOCARE MEDICAL LLC
ACI135A
In Commercial Distribution

  • 00847627001542 ()


  • Treponema pallidum antigen IVD, antibody

Spirochete - 00847627002075

No Description
BIOCARE MEDICAL LLC
API135AA
In Commercial Distribution

  • 00847627002075 ()


  • Treponema pallidum antigen IVD, antibody

Trinity Biotech - 05391516748049

Monkey Kidney 8 Well Slides, 12 each pack
MARDX DIAGNOSTICS, INC.
10-5808
In Commercial Distribution

  • 05391516748049 ()
10-5808

  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748032

Monkey Skeletal 4 Well Slides, 12 each pack
MARDX DIAGNOSTICS, INC.
10-5804
In Commercial Distribution

  • 05391516748032 ()
10-5804

  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748025

Anti Skeletal Antibody IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
10-5848
In Commercial Distribution

  • 05391516748025 ()
10-5848

  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay

IL-6 AccuLite CLIA Test System - 192 Wells - 00816870023984

No Description
MONOBIND, INC.
13275-300
In Commercial Distribution

  • 00816870023984 ()

  • Width: 7.75 Inch
13275-300B

  • Interleukin-6 receptor (IL-6r) IVD, kit, enzyme immunoassay (EIA)

IL-6 AccuLite CLIA Test System - 96 Wells - 00816870023977

No Description
MONOBIND, INC.
13275-300
In Commercial Distribution

  • 00816870023977 ()

  • Width: 7.75 Inch
13275-300A

  • Interleukin-6 receptor (IL-6r) IVD, kit, enzyme immunoassay (EIA)

IL-6 AccuBind ELISA Test System - 192 Wells - 00816870023960

No Description
MONOBIND, INC.
13225-300
In Commercial Distribution

  • 00816870023960 ()

  • Width: 7.75 Inch
13225-300B

  • Interleukin-6 receptor (IL-6r) IVD, kit, enzyme immunoassay (EIA)

IL-6 AccuBind ELISA Test System - 96 Wells - 00816870023953

No Description
MONOBIND, INC.
13225-300
In Commercial Distribution

  • 00816870023953 ()

  • Width: 7.75 Inch
13225-300A

  • Interleukin-6 receptor (IL-6r) IVD, kit, enzyme immunoassay (EIA)

RealTime - 00884999046757

Abbott RealTime ZIKA Control Kit
ABBOTT MOLECULAR INC.
09N27-080
In Commercial Distribution

  • 00884999046757 ()
09N27-080

  • Zika virus nucleic acid IVD, control
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