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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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ADVIA® Chemistry XTC Ecstasy Reagents - 00630414569857

Ecstasy - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378735
Not in Commercial Distribution

  • 00630414569857 ()
10378735

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry AMPH_2 Amphetamines_2 Reagents - 00630414568744

Amphetamines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378758
Not in Commercial Distribution

  • 00630414568744 ()
10378758

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

DSG-1 & DSG-3 ELISA Test System - 04987506017434

The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for the determination of autoantibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in human serum. The DSG-1 & DSG-3 ELISA Test System is intended for in vitro diagnostic use as an aid in diagnosis of certain pemphigus diseases.
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
DSG1 48 wells and DSG3 48 wells.
In Commercial Distribution

  • 04987506017434 ()
7594US

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

DSG-1 & DSG-3 ELISA Test System - 04987506015942

The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for the determination of autoantibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in human serum. The DSG-1 & DSG-3 ELISA Test System is intended for in vitro diagnostic use as an aid in diagnosis of certain pemphigus diseases. https://www.mblintl.com/products/rg-m7593-d
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
DSG1 48 wells and DSG3 48 wells.
Not in Commercial Distribution

  • 04987506015942 ()
7593US

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

CPR Uni-padz Electrode - 00847946024161

CPR UNI-PADZ, II
Zoll Medical Corporation
8900-000270
In Commercial Distribution

  • 00847946024161 ()


  • Multifunction cardiac electrode

LoFlo Sidestream Consumables - 00847946024086

KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, PEDIATRIC/INFANT, BOX OF 10, (REF: 3573INF-00)
Zoll Medical Corporation
9355-0315
In Commercial Distribution

  • 00847946024086 ()


  • Gas-sampling/monitoring respiratory tubing, single-use

LoFlo Sidestream Consumables - 00847946024079

KIT, ADAPTER, AIRWAY, PEDIATRIC/INFANT, BOX OF 10, (REF: 3572INF-00)
Zoll Medical Corporation
9355-0310
In Commercial Distribution

  • 00847946024079 ()


  • Gas dehumidification tubing set, single-use

REUSABLE AIRWAY ADAPTER - 00847946024055

NEONATAL REUSABLE AIRWAY ADAPTER
Zoll Medical Corporation
9355-0303
In Commercial Distribution

  • 00847946024055 ()


  • Physiologic-monitoring defibrillation system

REUSABLE AIRWAY ADAPTER - 00847946024048

ADULT REUSABLE AIRWAY ADAPTER
Zoll Medical Corporation
9355-0302
In Commercial Distribution

  • 00847946024048 ()


  • Physiologic-monitoring defibrillation system

LoFlo Sidestream Consumables - 00847946024017

KIT, ADAPTER, AIRWAY, W/DEHUMID TUBING, ADULT/PEDIATRIC, BOX OF 10, (REF: 3573ADU-00)
Zoll Medical Corporation
9355-0277
In Commercial Distribution

  • 00847946024017 ()


  • Gas-sampling/monitoring respiratory tubing, single-use
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