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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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SeCore™ B Locus Sequencing Kit, Single Amplification - 00814695022830

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022830 ()
22110D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ A Locus Sequencing Kit - 00814695022823

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022823 ()
22000D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ GSSP Kit - 00814695022519

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022519 ()
A11256

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ DPB1 Locus Sequencing Kit - 00814695021741

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021741 ()
5351025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ DRB1, DRB3, DRB4, DRB5 Locus Sequencing Kit Group Specific Set - 00814695021734

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021734 ()
5331025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ DRB1 Locus Sequencing Kit - 00814695021727

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021727 ()
5330025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ C Locus Sequencing Kit - 00814695021710

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021710 ()
5320025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ B Locus Sequencing Kit - Group Specific Set - 00814695021703

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021703 ()
5310025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ A Locus Sequencing Kit - 00814695021697

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021697 ()
5300025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

DRUGS OF ABUSE PLUS LEVEL 4 - B800DA4WBIMMUN0

DRUGS OF ABUSE PLUS LEVEL 4
UTAK LABORATORIES, INC.
DA+ 1 WB IMMUN
In Commercial Distribution

  • B800DA4WBIMMUN5 ()
  • B800DA4WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 1 WB IMMUN

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 4 - B800DA4WBFRIDH0

DRUGS OF ABUSE LEVEL 4
UTAK LABORATORIES, INC.
DA 4 WB F RIDH
In Commercial Distribution

  • B800DA4WBFRIDH5 ()
  • B800DA4WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 4 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE PLUS LEVEL 3 - B800DA3WBV2IMMUN0

DRUGS OF ABUSE PLUS LEVEL 3
UTAK LABORATORIES, INC.
DA+3 WB V2 IMMUN
In Commercial Distribution

  • B800DA3WBV2IMMUN5 ()
  • B800DA3WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+3 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE PLUS LEVEL 3 - B800DA3WBIMMUN0

DRUGS OF ABUSE PLUS LEVEL 3
UTAK LABORATORIES, INC.
DA+ 3 WB IMMUN
In Commercial Distribution

  • B800DA3WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 3 WB IMMUN

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 3 - B800DA3WBFRIDH0

DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DA 3 WB F RIDH
In Commercial Distribution

  • B800DA3WBFRIDH5 ()
  • B800DA3WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 3 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE PLUS LEVEL 2 - B800DA2WBV2IMMUN0

DRUGS OF ABUSE PLUS LEVEL 2
UTAK LABORATORIES, INC.
DA+2 WB V2 IMMUN
In Commercial Distribution

  • B800DA2WBV2IMMUN5 ()
  • B800DA2WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+2 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE PLUS LEVEL 2 - B800DA2WBIMMUN0

DRUGS OF ABUSE PLUS LEVEL 2
UTAK LABORATORIES, INC.
DA+ 2 WB IMMUN
In Commercial Distribution

  • B800DA2WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 2 WB IMMUN

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 2 - B800DA2WBFRIDH0

DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 WB F RIDH
In Commercial Distribution

  • B800DA2WBFRIDH5 ()
  • B800DA2WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 2 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 2 - B800DA2V2FWBTDHS0

DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 V2 F WB TDHS
In Commercial Distribution

  • B800DA2V2FWBTDHS5 ()
  • B800DA2V2FWBTDHS0 ()

  • Total Volume: 5 Milliliter
DA 2 V2 F WB TDHS

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 2 - B800DA2SFLLS0

DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 S F LLS
In Commercial Distribution

  • B800DA2SFLLS0 ()

  • Total Volume: 2 Milliliter
DA 2 S F LLS

  • Multiple drugs of abuse IVD, control

DA2FWBAHT - B800DA2FWBAHT0

DA2FWBAHT
UTAK LABORATORIES, INC.
DA 2 F WB AHT
In Commercial Distribution

  • B800DA2FWBAHT5 ()
  • B800DA2FWBAHT0 ()

  • Total Volume: 5 Milliliter
DA 2 F WB AHT

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE 1 - B800DA1WBVTS0

DRUGS OF ABUSE 1
UTAK LABORATORIES, INC.
DA 1 WB VTS
In Commercial Distribution

  • B800DA1WBVTS5 ()
  • B800DA1WBVTS0 ()

  • Total Volume: 25 Milliliter
DA 1 WB VTS

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE PLUS LEVEL 1 - B800DA1WBV2IMMUN0

DRUGS OF ABUSE PLUS LEVEL 1
UTAK LABORATORIES, INC.
DA+1 WB V2 IMMUN
In Commercial Distribution

  • B800DA1WBV2IMMUN5 ()
  • B800DA1WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+1 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE PLUS LEVEL 1 - B800DA1WBIMMUN0

DRUGS OF ABUSE PLUS LEVEL 1
UTAK LABORATORIES, INC.
DA+ 1 WB IMMUN
In Commercial Distribution

  • B800DA1WBIMMUN5 ()
  • B800DA1WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 1 WB IMMUN

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 1 - B800DA1WBFRIDH0

DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 WB F RIDH
In Commercial Distribution

  • B800DA1WBFRIDH5 ()
  • B800DA1WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 1 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 1 - B800DA1V2FWBTDHS0

DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 V2 F WB TDHS
In Commercial Distribution

  • B800DA1V2FWBTDHS5 ()
  • B800DA1V2FWBTDHS0 ()

  • Total Volume: 5 Milliliter
DA 1 V2 F WB TDHS

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE LEVEL 1 - B800DA1SFLLS0

DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 S F LLS
In Commercial Distribution

  • B800DA1SFLLS5 ()
  • B800DA1SFLLS0 ()

  • Total Volume: 2 Milliliter
DA 1 S F LLS

  • Multiple drugs of abuse IVD, control

DA SET 1 POSITIVE - B800DA1POSWBNC0

DA SET 1 POSITIVE
UTAK LABORATORIES, INC.
DA 1 POS WB NC
In Commercial Distribution

  • B800DA1POSWBNC5 ()
  • B800DA1POSWBNC0 ()

  • Total Volume: 2 Milliliter
DA 1 POS WB NC

  • Multiple-type clinical chemistry analyte profile IVD, control

DA SET 1 POSITIVE - B800DA1POSSNC0

DA SET 1 POSITIVE
UTAK LABORATORIES, INC.
DA 1 POS S NC
In Commercial Distribution

  • B800DA1POSSNC5 ()
  • B800DA1POSSNC0 ()

  • Total Volume: 2 Milliliter
DA 1 POS S NC

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DA1FWBAHT - B800DA1FWBAHT0

DA1FWBAHT
UTAK LABORATORIES, INC.
DA 1 F WB AHT
In Commercial Distribution

  • B800DA1FWBAHT5 ()
  • B800DA1FWBAHT0 ()

  • Total Volume: 5 Milliliter
DA 1 F WB AHT

  • Multiple-type clinical chemistry analyte profile IVD, control

DA SET 1 CUTOFF - B800DA1CUTWBNC0

DA SET 1 CUTOFF
UTAK LABORATORIES, INC.
DA 1 CUT WB NC
In Commercial Distribution

  • B800DA1CUTWBNC5 ()
  • B800DA1CUTWBNC0 ()

  • Total Volume: 2 Milliliter
DA 1 CUT WB NC

  • Multiple-type clinical chemistry analyte profile IVD, control
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