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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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The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris 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.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
SEKISUI DIAGNOSTICS, LLC
1032
In Commercial Distribution

  • 10742860100397 ()
  • 00742860100390 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Acucy Influenza A&B Test Kit
SEKISUI DIAGNOSTICS, LLC
1010
In Commercial Distribution

  • 00742860100376 ()
  • 10742860100373 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
1031
Not in Commercial Distribution

  • 00742860100345 ()


  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD
OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
1007
In Commercial Distribution

  • 00742860100239 ()
  • 10742860100236 ()
1007

  • Nasopharyngeal aspirate container IVD
OSOM Ultra Flu A&B 25T Kit
SEKISUI DIAGNOSTICS, LLC
1006
In Commercial Distribution

  • 00742860100222 ()
  • 10742860100229 ()
1006

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Tinted Liquid
JBC and Company
A
In Commercial Distribution

  • D851A00 ()
A

  • Dental appliance fabrication material, resin
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system
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