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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® 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
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695020461 ()
LTSPSAPBU

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695020454 ()
LTSPSAPBR

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. QUANTA Flash ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.
INOVA DIAGNOSTICS, INC.
701187
In Commercial Distribution

  • 08426950601944 ()


  • Beta-2-glycoprotein I antibody IVD, control
1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgA High Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative.
INOVA DIAGNOSTICS, INC.
701242
In Commercial Distribution

  • 08426950597353 ()


  • Beta-2-glycoprotein I antibody IVD, control
1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.
INSTRUMENTATION LABORATORY COMPANY
00009800022
In Commercial Distribution

  • 08426951301706 ()
  • 18426951301703 ()
00009800022

  • Beta-2-glycoprotein I antibody IVD, control
1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgG High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albumin, stabilizers and preservative.
INOVA DIAGNOSTICS, INC.
701247
In Commercial Distribution

  • 08426950595250 ()


  • Beta-2-glycoprotein I antibody IVD, control
1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative.
INOVA DIAGNOSTICS, INC.
701252
In Commercial Distribution

  • 08426950595038 ()


  • Beta-2-glycoprotein I antibody IVD, control
No Description
CareDx AB
101.708-24u
In Commercial Distribution

  • 07340035507147 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.701-06u
In Commercial Distribution

  • 07340035507048 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.701-24u
In Commercial Distribution

  • 07340035507024 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211049 ()


  • Troponin I IVD, reagent
CARTRIDGE, cTnI
ABBOTT POINT OF CARE INC.
06P23-25
Not in Commercial Distribution

  • 10054749001986 ()
  • 00054749001989 ()
06P23-25

  • Troponin I IVD, reagent
TROPONIN CARTRIDGE
ABBOTT POINT OF CARE INC.
03P90-25
In Commercial Distribution

  • 10054749000187 ()
  • 00054749000180 ()
03P90-25

  • Troponin I IVD, reagent
The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS
In Commercial Distribution

  • 10888234500254 ()
PAKPLUS

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls
INSTRUMENTATION LABORATORY COMPANY
0009802116
In Commercial Distribution

  • 08426950497028 ()
0009802116

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, control
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls
INSTRUMENTATION LABORATORY COMPANY
0009802112
In Commercial Distribution

  • 08426950497011 ()
0009802112

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, control
EliA ß2-Glycoprotein I IgM Well
Phadia AB
DECC055330
In Commercial Distribution

  • 07333066010809 ()
  • 07333066014760 ()
DECC055330

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
EliA ß2-Glycoprotein I IgG Well
Phadia AB
DECC055320
In Commercial Distribution

  • 07333066010793 ()
  • 07333066014753 ()
DECC055320

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
EliA ß2-Glycoprotein I IgA Well
Phadia AB
DECC055310
In Commercial Distribution

  • 07333066010786 ()
  • 07333066014746 ()
DECC055310

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-3000N
In Commercial Distribution

  • 05060169695986 ()


  • Procollagen type I C-terminal propeptide (PICP) IVD, reagent
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-3930
In Commercial Distribution

  • 05060169690295 ()


  • Insulin-like growth factor I (IGF1) IVD, control
Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit
BIO-RAD LABORATORIES, INC.
425-2100
In Commercial Distribution

  • 00847817018251 ()

  • 96 Tests
425-2100

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2080
In Commercial Distribution

  • 00847817018244 ()

  • 96 Tests
425-2080

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit
BIO-RAD LABORATORIES, INC.
425-2060
In Commercial Distribution

  • 00847817018237 ()

  • 96 Tests
425-2060

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
IGF - IMMULITE - CTL - 2x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385387
In Commercial Distribution

  • 00630414953212 ()
LGCOCM

  • Insulin-like growth factor I (IGF1) IVD, control
IGF-I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387979
In Commercial Distribution

  • 00630414973647 ()
LGFCVM

  • Insulin-like growth factor I (IGF1) IVD, control
B2GP1 Screen ELISA
IMMCO DIAGNOSTICS, INC.
5152S
Not in Commercial Distribution

  • 00845714002458 ()

  • 96 determinations
5152S

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
B2GP1 IgM ELISA
IMMCO DIAGNOSTICS, INC.
5152M
Not in Commercial Distribution

  • 00845714002441 ()

  • 96 determinations
5152M

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
B2GP1 IgG ELISA
IMMCO DIAGNOSTICS, INC.
5152G
Not in Commercial Distribution

  • 00845714002434 ()

  • 96 determinations
5152G

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
B2GP1 IgA ELISA
IMMCO DIAGNOSTICS, INC.
5152A
Not in Commercial Distribution

  • 00845714002427 ()

  • 96 determinations
5152A

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Anti-B2-GP1 IgG Antibody ELISA
IMMCO DIAGNOSTICS, INC.
1152M
Not in Commercial Distribution

  • 00845714000645 ()

  • 96 DETERMINATIONS
1152M

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Anti-B2-GP1 IgG Antibody ELISA
IMMCO DIAGNOSTICS, INC.
1152G
Not in Commercial Distribution

  • 00845714000638 ()

  • 96 DETERMINATIONS
1152G

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
IGF-1-RIA-CT
Diasource Immunoassays S.A. SA
KIP1588
In Commercial Distribution

  • 05400569000520 ()


  • Insulin-like growth factor I (IGF1) IVD, kit, radioimmunoassay
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117019109 ()
LSPSAB2

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018935 ()
LSMUTRS

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018928 ()
LSMS

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018898 ()
LS2PRAS

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018881 ()
LS2ASP01

  • HLA class I & II antibody screening IVD, kit, multiplex
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