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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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ONLINE TDM Methotrexate - 07613336224823

No Description
Roche Diagnostics GmbH
09230815190
In Commercial Distribution

  • 07613336224823 ()
09230815190

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ONLINE TDM Methotrexate - 07613336224816

No Description
Roche Diagnostics GmbH
09230785190
In Commercial Distribution

  • 07613336224816 ()
09230785190

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Elecsys HBsAg II Auto Confirm - 07613336183137

No Description
Roche Diagnostics GmbH
08741034162
In Commercial Distribution

  • 07613336183137 ()
08741034162

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Elecsys Anti-HBc II - 07613336183106

No Description
Roche Diagnostics GmbH
09014926162
In Commercial Distribution

  • 07613336228487 ()
  • 07613336183106 ()
09014926162

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg II - 07613336183076

No Description
Roche Diagnostics GmbH
08814848162
In Commercial Distribution

  • 07613336228456 ()
  • 07613336183076 ()
08814848162

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

ARK™ Methotrexate II Dilution Buffer - 00812101031223

ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator

Syva® Emit® Methotrexate Assay - 00842768001383

Syva® Emit® Methotrexate Assay
Siemens Healthcare Diagnostics Inc.
10445368
In Commercial Distribution

  • 00842768001383 ()
6L119UL

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Ace + 7 - 10888551045278

HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
STERILMED, INC.
HARH45R
Not in Commercial Distribution

  • 10888551045278 ()
HARH45R

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

Ace + 7 - 10888551045247

HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
STERILMED, INC.
HARH36R
Not in Commercial Distribution

  • 10888551045247 ()
HARH36R

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

Ace + 7 - 10888551045230

HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
STERILMED, INC.
HARH23R
Not in Commercial Distribution

  • 10888551045230 ()
HARH23R

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
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