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 Class Implantable

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Myoglobin Flex® reagent cartridge, 100 tests
Siemens Healthcare Diagnostics Inc.
10445099
In Commercial Distribution

  • 00842768015335 ()
  • 00630414004747 ()
K6422

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests
Siemens Healthcare Diagnostics Inc.
10445097
In Commercial Distribution

  • 00842768015328 ()
  • 00630414004723 ()
K6420

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Urine Methadone Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445111
In Commercial Distribution

  • 00842768015304 ()
  • 00630414004846 ()
K5090

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Urine Barbiturates Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445117
In Commercial Distribution

  • 00842768015076 ()
  • 00630414004907 ()
K5096

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Amylase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10445154
In Commercial Distribution

  • 00842768015069 ()
  • 00630414005188 ()
K3017

  • Total amylase IVD, kit, spectrophotometry
Urine Amphetamine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445112
In Commercial Distribution

  • 00842768015052 ()
  • 00630414004853 ()
K5091

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Albumin Flex® reagent cartridge, 1200 tests
Siemens Healthcare Diagnostics Inc.
10445165
In Commercial Distribution

  • 00842768015021 ()
  • 00630414005256 ()
K1013

  • Albumin IVD, kit, spectrophotometry
Acetaminophen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445110
In Commercial Distribution

  • 00842768015014 ()
  • 00630414004839 ()
K5088

  • Acetaminophen IVD, kit, spectrophotometry
Urine Ecstasy Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444921
In Commercial Distribution

  • 00842768014710 ()
  • 00630414004075 ()
DF109

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
ALDL Calibrator, 2x3x2ml
Siemens Healthcare Diagnostics Inc.
10444996
In Commercial Distribution

  • 00842768014093 ()
  • 00630414017037 ()
DC131

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator
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