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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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ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control
ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0034
In Commercial Distribution

  • 00816784020130 ()
2000-0034

  • Multiple infectious organism/newborn TORCH screen IVD, control
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
LIVANOVA USA, INC.
Duo Cannula
In Commercial Distribution

  • 10803622128070 ()
  • 00803622128073 ()


  • Aorta cannula
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
PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080095
In Commercial Distribution

  • M220P0800955 ()
  • M220P0800953 ()
P080095

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

  • 40195327683154 ()
  • 10195327683153 ()
DYNJ908719B

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