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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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PTS404 PTS BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613706
In Commercial Distribution

  • 04046964311031 ()
613706

  • Cardiac sizing catheter
PTS403 PTS BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613705
In Commercial Distribution

  • 04046964311017 ()
613705

  • Cardiac sizing catheter
PTS305 PTS BALLOON 30MM X 5CM X 80 CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613704
In Commercial Distribution

  • 04046964310997 ()
613704

  • Cardiac sizing catheter
PTS304 PTS BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613703
In Commercial Distribution

  • 04046964310973 ()
613703

  • Cardiac sizing catheter
PTS303 PTS BALLOON 30MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613702
In Commercial Distribution

  • 04046964310959 ()
613702

  • Cardiac sizing catheter
PTS253 PTS BALLOON 25MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613701
In Commercial Distribution

  • 04046964310935 ()
613701

  • Cardiac sizing catheter
PTS203 PTS BALLOON 20MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613700
In Commercial Distribution

  • 04046964310911 ()
613700

  • Cardiac sizing catheter
H.pylori Rapid Test
Cardinal Health 200, LLC
B1077-25
Not in Commercial Distribution

  • 50885380020283 ()
  • 20885380020282 ()
  • 10885380020285 ()
B1077-25

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
No Description
Biohit Healthcare (Hefei) Co., Ltd.
25 Tests/Kit
In Commercial Distribution

  • 06973774259803 ()
  • 16973774259800 ()
REF:207.01.25.02

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