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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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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
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
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
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804805029 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-034
In Commercial Distribution

  • 00811806011530 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 34.0000 Millimeter
9-SB-034

  • Cardiac sizing catheter
TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ908719B
In Commercial Distribution

  • 40195327683154 ()
  • 10195327683153 ()
DYNJ908719B

  • General surgical procedure kit, non-medicated, single-use
* CEKA SOL G
Alphadent NV
CS20
In Commercial Distribution

  • 04260576941763 ()
  • 14260576941760 ()

  • Outer Diameter: 1.15 Millimeter
  • tube solder
CS20

  • Dental brazing alloy
TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ904995G
In Commercial Distribution

  • 10195327165680 ()
DYNJ904995G

  • General surgical procedure kit, non-medicated, single-use
DR G ILESI
MEDLINE INDUSTRIES, INC.
PAIN1812
In Commercial Distribution

  • 40195327141111 ()
  • 10195327141110 ()
PAIN1812

  • General surgical procedure kit, non-medicated, single-use
TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ904995F
In Commercial Distribution

  • 10195327116668 ()
DYNJ904995F

  • General surgical procedure kit, non-medicated, single-use
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