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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Urine Cocaine Metabolite Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444920
In Commercial Distribution

  • 00842768005824 ()
  • 00630414004068 ()
DF92A

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Urine Amphetamine/Methamphetamine Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444926
In Commercial Distribution

  • 00842768005817 ()
  • 00630414004129 ()
DF91B

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Urine Methadone Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444922
In Commercial Distribution

  • 00842768005800 ()
  • 00630414004082 ()
DF90A

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Acetaminophen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444916
In Commercial Distribution

  • 00842768005787 ()
  • 00630414004037 ()
DF88

  • Acetaminophen IVD, kit, spectrophotometry
Carbamazepine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444930
In Commercial Distribution

  • 00842768005770 ()
  • 00630414004167 ()
DF87

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Total Iron Binding Capacity Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444944
In Commercial Distribution

  • 00842768005756 ()
  • 00630414004310 ()
DF84

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444908
In Commercial Distribution

  • 00842768005626 ()
  • 00630414003962 ()
DF65

  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Glucose Flex® reagent cartridge, 1440 tests
Siemens Healthcare Diagnostics Inc.
10444971
In Commercial Distribution

  • 00842768005541 ()
  • 00630414004501 ()
DF40

  • Glucose IVD, kit, spectrophotometry
C-Reactive Protein Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444894
Not in Commercial Distribution

  • 00842768005527 ()
  • 00630414003856 ()
DF37

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Digitoxin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444932
In Commercial Distribution

  • 00842768005510 ()
  • 00630414004174 ()
DF36

  • Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Digoxin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444941
In Commercial Distribution

  • 00842768005503 ()
  • 00630414004280 ()
DF35A

  • Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Cholesterol Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444891
In Commercial Distribution

  • 00842768005466 ()
  • 00630414003849 ()
DF27

  • Total cholesterol lipid IVD, kit, spectrophotometry
Urinary/Cerebrospinal Fluid Protein Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444950
In Commercial Distribution

  • 00842768005459 ()
  • 00630414004365 ()
DF26

  • Total protein IVD, kit, spectrophotometry
Salicylate Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444915
In Commercial Distribution

  • 00842768005435 ()
  • 00630414004020 ()
DF20

  • Salicylate IVD, kit, spectrophotometry
Amylase Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444965
In Commercial Distribution

  • 00842768005404 ()
  • 00630414004471 ()
DF17A

  • Total amylase IVD, kit, spectrophotometry
Lactic Acid Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444961
In Commercial Distribution

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate IVD, kit, spectrophotometry
Tobramycin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444928
In Commercial Distribution

  • 00842768005381 ()
  • 00630414004143 ()
DF14

  • Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Enzymatic Carbonate Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10444972
In Commercial Distribution

  • 00842768005374 ()
  • 00630414004518 ()
DF137

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
Lithium Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444939
In Commercial Distribution

  • 00842768005367 ()
  • 00630414004266 ()
DF132

  • Lithium therapeutic drug monitoring IVD, kit, spectrophotometry
Automated LDL Cholesterol Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444890
In Commercial Distribution

  • 00842768005350 ()
  • 00630414003832 ()
DF131

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Albumin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444975
In Commercial Distribution

  • 00842768005343 ()
  • 00630414004525 ()
DF13

  • Albumin IVD, kit, spectrophotometry
Gentamicin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444927
In Commercial Distribution

  • 00842768005336 ()
  • 00630414004136 ()
DF12

  • Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
N-Acetylprocainamide Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444936
In Commercial Distribution

  • 00842768005299 ()
  • 00630414004235 ()
DF111

  • N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Drug Calibrator II, 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10445005
In Commercial Distribution

  • 00842768005176 ()
  • 00630414017082 ()
DC49D

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Drugs of Abuse Negative Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445032
In Commercial Distribution

  • 00842768005145 ()
  • 00630414004624 ()
DC44A

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Positive Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445033
In Commercial Distribution

  • 00842768005138 ()
  • 00630414004631 ()
DC43A

  • Multiple drugs of abuse IVD, control
Revised C-Reactive Protein Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445026
In Commercial Distribution

  • 00842768005107 ()
  • 00630414017204 ()
DC34

  • C-reactive protein (CRP) IVD, calibrator
C-Reactive Protein Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10444988
Not in Commercial Distribution

  • 00842768005084 ()
  • 00630414016979 ()
DC30

  • C-reactive protein (CRP) IVD, calibrator
Pseudocholinesterase Verifier, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10444987
In Commercial Distribution

  • 00842768005077 ()
  • 00630414016962 ()
DC28

  • Pseudocholinesterase IVD, control
Stratus® CS STAT Fluorometric Analyzer Rotor is an in vitro diagnostics device which is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445088
In Commercial Distribution

  • 00842768004674 ()
  • 00630414009988 ()
CROTOR

  • Centrifuge rotor, fixed angle
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