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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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STERILE-R
Dynarex Corporation
43162
In Commercial Distribution

  • 00810180841580 ()
  • 00840117331365 ()
  • 00840117330436 ()


  • Microbial specimen inoculation/streaking/colony-picking instrument IVD
No Description
Dynarex Corporation
43161
In Commercial Distribution

  • 00810180841573 ()
  • 00840117331358 ()
  • 00840117330429 ()


  • Microbial specimen inoculation/streaking/colony-picking instrument IVD
STERILE-R
Dynarex Corporation
43160
In Commercial Distribution

  • 00810180841566 ()
  • 00840117331341 ()
  • 00840117330399 ()


  • Microbial specimen inoculation/streaking/colony-picking instrument IVD
The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence.
Spectral Medical Inc
84018-01
In Commercial Distribution

  • B17384018010 ()
8401801

  • Multiple clinical chemistry analyser IVD, laboratory
Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actions performed and the user prompts. The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
Spectral Medical Inc
84007
In Commercial Distribution

  • B173840070 ()

  • Not Applicable
84007

  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
08106568001
In Commercial Distribution

  • 07613336146644 ()
08106568001

  • Slide-mounted-tissue dissection system IVD
No Description
Roche Molecular Systems, Inc.
08106550001
Not in Commercial Distribution

  • 07613336146620 ()
08106550001

  • Slide-mounted-tissue dissection system IVD
No Description
Roche Molecular Systems, Inc.
08106533001
In Commercial Distribution

  • 07613336146613 ()
08106533001

  • Laboratory waste receptacle IVD
No Description
Roche Molecular Systems, Inc.
08106525001
Not in Commercial Distribution

  • 07613336146606 ()
08106525001

  • Slide-mounted-tissue dissection system excision tip IVD
No Description
Roche Molecular Systems, Inc.
08106517001
In Commercial Distribution

  • 07613336146590 ()
08106517001

  • Slide-mounted-tissue dissection system excision tip IVD
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