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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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The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376323
In Commercial Distribution

  • 00630414578330 ()
10376323

  • Urine analyser IVD, point-of-care
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
10379677
In Commercial Distribution

  • 00630414572314 ()
10379677

  • Urine analyser IVD, point-of-care
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376322
In Commercial Distribution

  • 00630414571263 ()
10376322

  • Multichannel clinical chemistry analyser IVD, laboratory
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)
Amphetamines - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378758
Not in Commercial Distribution

  • 00630414568744 ()
10378758

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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)
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, II
Zoll Medical Corporation
8900-000270
In Commercial Distribution

  • 00847946024161 ()


  • Multifunction cardiac electrode
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
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
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