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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
DC D AND C PROCEDURE PACK
Cardinal Health 200, LLC
SMAHDDPAGB
In Commercial Distribution

  • 50197106559640 ()
  • 10197106559642 ()
SMAHDDPAGB

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
KIT, BLO D C
Cardinal Health 200, LLC
PBCGDCBL4
In Commercial Distribution

  • 50197106558353 ()
  • 10197106558355 ()
PBCGDCBL4

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
GYNE PACK
Cardinal Health 200, LLC
SMACGGPINA
In Commercial Distribution

  • 50197106558025 ()
  • 10197106558027 ()
SMACGGPINA

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
D C DILATION CURETTAGE PACK
Cardinal Health 200, LLC
SMADHDCPMJ
In Commercial Distribution

  • 50197106552498 ()
  • 10197106552490 ()
SMADHDCPMJ

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
LAPAROSCOPIC GYN PACK
Cardinal Health 200, LLC
SMA21GLS10
In Commercial Distribution

  • 50197106540457 ()
  • 10197106540459 ()
SMA21GLS10

  • Laparoscopic surgical procedure kit, non-medicated, single-use
D AND C PACK
Cardinal Health 200, LLC
SMA73DCKP3
In Commercial Distribution

  • 50197106533909 ()
  • 10197106533901 ()
SMA73DCKP3

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
NASAL PACK
Cardinal Health 200, LLC
SEN45NPGH2
In Commercial Distribution

  • 50197106598045 ()
  • 10197106598047 ()
SEN45NPGH2

  • ENT surgical procedure kit, non-medicated, single-use
D C PACK
Cardinal Health 200, LLC
SMA43DIEJC
In Commercial Distribution

  • 50197106594887 ()
  • 10197106594889 ()
SMA43DIEJC

  • Obstetrical/gynaecological surgical procedure kit, medicated
KIT, D AND C
Cardinal Health 200, LLC
PB45DCVH3
In Commercial Distribution

  • 50197106592883 ()
  • 10197106592885 ()
PB45DCVH3

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
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