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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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For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10341140
In Commercial Distribution

  • 00630414118413 ()
  • 00630414009742 ()
478942000

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
No Description
Tasso Inc.
PN0583-02
In Commercial Distribution

  • 10850038691117 ()
  • 00850038691110 ()
  • 20850038691114 ()
  • 30850038691111 ()


  • Dried blood spot collection receptacle IVD
For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems
Siemens Healthcare Diagnostics Products GmbH
10385332
In Commercial Distribution

  • 00842768028441 ()
LKPM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385229
In Commercial Distribution

  • 00842768028434 ()
L2KPM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385231
In Commercial Distribution

  • 00842768028427 ()
  • 00842768019708 ()
L2PWSM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385393
In Commercial Distribution

  • 00842768028410 ()
  • 00842768019760 ()
LPWS2

  • Wash/cleaning solution IVD, automated/semi-automated system
Cell wall polysaccharide
Ssi Diagnostica A/S
68866
In Commercial Distribution

  • 05713106688663 ()
68866

  • Streptococcus pneumoniae total antibody IVD, reagent
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
401020
In Commercial Distribution

  • 00657498000731 ()
401020

  • Single-channel clinical chemistry analyser IVD, point-of-care
Fat microsizing unit.
Syntr Health Technologies, Inc
90-1006
In Commercial Distribution

  • 00860005496730 ()
90-1006

  • Autologous adipose tissue noninvasive processing set
Absolute Polishers™; Point Shapers (non-diamond)
PARKELL, INC.
S080
Not in Commercial Distribution

  • 10810000526007 ()
  • 00810000526000 ()
S080

  • Dental abrasive point, single-use
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