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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 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
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
CPAP Nasal Cannula with Bonnet,Babies 1000 g >1500 g
Cardinal Health, Inc.
8888163030
In Commercial Distribution

  • 20884527007100 ()
  • 10884527007103 ()

  • Clothing Size,Small,N/A;
8888163030

  • Nasal oxygen cannula, CPAP
Diaper/Lap Sponge Scale, Digital, 4000 g x 1 g
CARDINAL SCALE MANUFACTURING COMPANY
AP-4KD
In Commercial Distribution

  • 00809161142709 ()


  • Medical/surgical procedure scale, electronic
SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Palm Operator
In Commercial Distribution

  • 05060727270068 ()
900059

  • Pain management medication delivery system
Sterile SAFIRA 20 mL syringe (NRFit)
MEDOVATE LIMITED
SAFIRA NRFit Syringe
In Commercial Distribution

  • 35060727270052 ()
  • 05060727270051 ()
900058

  • Pain management medication delivery system
Sterile SAFIRA 20 mL syringe (Luer)
MEDOVATE LIMITED
SAFIRA Syringe
In Commercial Distribution

  • 35060727270038 ()
  • 05060727270037 ()
900016

  • Pain management medication delivery system
SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes
MEDOVATE LIMITED
SAFIRA Driver
In Commercial Distribution

  • 05060727270020 ()
900029

  • Pain management medication delivery system
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