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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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Trinity Biotech - 05391516747714

EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +) - 05055273216431

ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10350
In Commercial Distribution

  • 05055273216431 ()
SR10350

  • Multiple infectious organism/newborn TORCH screen IVD, control

SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +) - 05055273216424

ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. ToRCH IgM Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgM Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10349
In Commercial Distribution

  • 05055273216424 ()
SR10349

  • Multiple infectious organism/newborn TORCH screen IVD, control

SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +) - 05055273216417

ToRCH IgG Positive Control is intended for use with in vitro assays for determination of IgG antibodies to Cytomegalovirus (CMV), IgG antibodies to Rubella Virus, IgG antibodies to Toxoplasma gondii, IgG antibodies to Herpes Simplex Virus Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Measles Virus, IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori IgG antibodies to Treponema pallidum (Syphilis), IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH IgG Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgG Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10348
In Commercial Distribution

  • 05055273216417 ()
SR10348

  • Multiple infectious organism/newborn TORCH screen IVD, control

SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -) - 05055273216400

ToRCH Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting IgG and IgM antibodies to Cytomegalovirus (CMV), IgG and IgM antibodies to Rubella virus, IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Herpes Simplex Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Rubeola Virus (Measles), IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori, IgG antibodies to Treponema pallidum (Syphilis), IgG and IgM antibodies to the Viral Capsid Antigen of Epstein-Barr virus (EBV VCA) and IgG antibodies to the Viral Polypeptide Nuclear Antigen of Epstein-Barr Virus (EBV EBNA IgG).
RANDOX LABORATORIES LIMITED
SR10347
In Commercial Distribution

  • 05055273216400 ()
SR10347

  • Multiple infectious organism/newborn TORCH screen IVD, control

Signify® - 10815845020079

No Description
ALERE SAN DIEGO, INC.
01P53-25
Not in Commercial Distribution

  • 10815845020079 ()
  • 00815845020072 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Clearview® - 10815845020048

No Description
ALERE SAN DIEGO, INC.
92405
Not in Commercial Distribution

  • 10815845020048 ()
  • 00815845020041 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

VIROTROL - 03610520540718

VIROTROL ToRCH-M (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00117A
In Commercial Distribution

  • 03610520540718 ()
00117A

  • Multiple infectious organism/newborn TORCH screen IVD, control

Health o meter professional - 00892076002312

Mechanical Dial Scale
Pelstar, LLC
386KGS-01
In Commercial Distribution

  • 00892076002312 ()


  • Laboratory scale, mechanical

Health o meter professional - 00892076002305

Mechanical Dial Scale
Pelstar, LLC
386S01
In Commercial Distribution

  • 00892076002305 ()


  • Laboratory scale, mechanical

Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663

A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Detector H. pylori - 10722355002023

Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-30
In Commercial Distribution

  • 20722355002020 ()
  • 10722355002023 ()
  • 80722355002022 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Detector H. pylori - 10722355002016

Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-10
In Commercial Distribution

  • 20722355002013 ()
  • 10722355002016 ()
  • 80722355002015 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Rapid Response - 10722066005115

COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Venos Occlusion Balloon Catheter - 00836559007111

Occlusion Balloon Catheter, 6F
Oscor Inc.
V0612015
Not in Commercial Distribution

  • 00836559007111 ()

  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
  • Required Syringe Size 2.0 cc
  • Length: 120 Centimeter
V0612015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007104

Occlusion Balloon Catheter, 6F
Oscor Inc.
V0610015
In Commercial Distribution

  • 00836559007104 ()

  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
  • Length: 100 Centimeter
  • Required Syringe Size 2.0 cc
V0610015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007098

Occlusion Balloon Catheter, 6F
Oscor Inc.
V068015
Not in Commercial Distribution

  • 00836559007098 ()

  • Required Syringe Size 2.0 cc
  • Length: 80 Centimeter
  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
V068015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007081

Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510015
Not in Commercial Distribution

  • 00836559007081 ()

  • Outer Diameter: 1.7 Millimeter
  • Balloon Diameter 15 mm
  • Length: 100 Centimeter
  • Required Syringe Size 2.0 cc
V0510015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007074

Occlusion Balloon Catheter, 5F
Oscor Inc.
V058015
Not in Commercial Distribution

  • 00836559007074 ()

  • Outer Diameter: 1.7 Millimeter
  • Balloon Diameter 15 mm
  • Required Syringe Size 2.0 cc
  • Length: 80 Centimeter
V058015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006930

Occlusion Balloon Catheter, 6F
Oscor Inc.
V0610010
In Commercial Distribution

  • 00836559006930 ()

  • Length: 100 Centimeter
  • Required Syringe Size 0.75 cc
  • Balloon Diameter 10 mm
  • Outer Diameter: 2 Millimeter
V0610010

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006923

Occlusion Balloon Catheter, 6F
Oscor Inc.
V068010
In Commercial Distribution

  • 00836559006923 ()

  • Balloon Diameter 10 mm
  • Required Syringe Size 0.75 cc
  • Length: 80 Centimeter
  • Outer Diameter: 2 Millimeter
V068010

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006916

Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510010
Not in Commercial Distribution

  • 00836559006916 ()

  • Length: 100 Centimeter
  • Balloon Diameter 10 mm
  • Outer Diameter: 1.7 Millimeter
  • Required Syringe Size 0.75 cc
V0510010

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006909

Occlusion Balloon Catheter, 5F
Oscor Inc.
V058010
In Commercial Distribution

  • 00836559006909 ()

  • Balloon Diameter 10 mm
  • Outer Diameter: 1.7 Millimeter
  • Required Syringe Size 0.75 cc
  • Length: 80 Centimeter
V058010

  • Cardiac sizing catheter

PTS-X™ - 04046964512117

PTSX353 PTSX BALLOON 35MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613745
Not in Commercial Distribution

  • 04046964512117 ()
613745

  • Cardiac sizing catheter

PTS-X™ - 04046964512094

PTSX304 PTSX BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613743
In Commercial Distribution

  • 04046964512094 ()
613743

  • Cardiac sizing catheter

PTS-X™ - 04046964512070

PTSX254 PTSX BALLOON 25MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613741
Not in Commercial Distribution

  • 04046964512070 ()
613741

  • Cardiac sizing catheter

PTS-X™ - 04046964512056

PTSX204 PTSX BALLOON 20MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613739
In Commercial Distribution

  • 04046964512056 ()
613739

  • Cardiac sizing catheter

PTS-X™ - 04046964512032

PTSX154 PTSX BALLOON 15MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613737
Not in Commercial Distribution

  • 04046964512032 ()
613737

  • Cardiac sizing catheter

PTS-X™ - 04046964512025

PTSX153 PTSX BALLOON 15MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613736
In Commercial Distribution

  • 04046964512025 ()
613736

  • Cardiac sizing catheter

PTS-X™ - 04046964512018

PTSX152 PTSX BALLOON 15MM X 2CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613735
Not in Commercial Distribution

  • 04046964512018 ()
613735

  • Cardiac sizing catheter

PTS-X™ - 04046964512001

PTSX123 PTSX BALLOON 12MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613734
Not in Commercial Distribution

  • 04046964512001 ()
613734

  • Cardiac sizing catheter

PTS-X™ - 04046964511998

PTSX122 PTSX BALLOON 12MM X 2CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613733
Not in Commercial Distribution

  • 04046964511998 ()
613733

  • Cardiac sizing catheter

PTS-X™ - 04046964511981

PTSX103 PTSX BALLOON 10MM X 3 CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613732
In Commercial Distribution

  • 04046964511981 ()
613732

  • Cardiac sizing catheter

PTS-X™ - 04046964511974

PTSX102 PTSX BALLOON 10MM X 2 CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613731
Not in Commercial Distribution

  • 04046964511974 ()
613731

  • Cardiac sizing catheter

PTS-X™ - 04046964511967

PTSX101 PTSX BALLOON 10MM X 1 CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613730
Not in Commercial Distribution

  • 04046964511967 ()
613730

  • Cardiac sizing catheter

PTS-X™ - 04046964512186

PTSX406 PTSX BALLOON 40MM X 6CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613752
Not in Commercial Distribution

  • 04046964512186 ()
613752

  • Cardiac sizing catheter

PTS-X™ - 04046964512179

PTSX405 PTSX BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613751
In Commercial Distribution

  • 04046964512179 ()
613751

  • Cardiac sizing catheter

PTS-X™ - 04046964512162

PTSX404 PTSX BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613750
Not in Commercial Distribution

  • 04046964512162 ()
613750

  • Cardiac sizing catheter

PTS-X™ - 04046964512155

PTSX403 PTSX BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613749
In Commercial Distribution

  • 04046964512155 ()
613749

  • Cardiac sizing catheter

PTS-X™ - 04046964512148

PTSX356 PTSX BALLOON 35MM X 6CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613748
In Commercial Distribution

  • 04046964512148 ()
613748

  • Cardiac sizing catheter
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