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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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Accula Dock - B540D20000

The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays - 00884883007376

No Description
Microgenics Corporation
10027480-U
In Commercial Distribution

  • 00884883007376 ()


  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control

AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 Wells - 00816870020433

No Description
MONOBIND, INC.
8425-300
In Commercial Distribution

  • 00816870020433 ()

  • Width: 12 Inch
8425-300D

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 96 Wells - 00816870020280

No Description
MONOBIND, INC.
7875-300
In Commercial Distribution

  • 00816870020280 ()

  • Width: 7.75 Inch
7875-300A

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 Wells - 00816870020440

No Description
MONOBIND, INC.
8425-300
In Commercial Distribution

  • 00816870020440 ()

  • Width: 12 Inch
8425-300E

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 192 Wells - 00816870020297

No Description
MONOBIND, INC.
7875-300
In Commercial Distribution

  • 00816870020297 ()

  • Width: 7.75 Inch
7875-300B

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 Wells - 00816870022116

No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022116 ()

  • Width: 12 Inch
8475-300D

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

Folate, Vit B12 Anemia Panel AccuLite VAST CLIA Test System - 96 Wells - 00816870021966

No Description
MONOBIND, INC.
7825-300
In Commercial Distribution

  • 00816870021966 ()

  • Width: 7.75 Inch
7825-300A

  • Folate (vitamin B9) IVD, kit, enzyme immunoassay (EIA)

T3, T4, TSH Thyroid Panel AccuBind VASTAccuBind ELISA Test System - 480 Wells - 00816870021898

No Description
MONOBIND, INC.
8025-300
In Commercial Distribution

  • 00816870021898 ()

  • Width: 7.75 Inch
8025-300D

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 Wells - 00816870022123

No Description
MONOBIND, INC.
8475-300
In Commercial Distribution

  • 00816870022123 ()

  • Width: 12 Inch
8475-300E

  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
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