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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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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)
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-I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387979
In Commercial Distribution

  • 00630414973647 ()
LGFCVM

  • Insulin-like growth factor I (IGF1) IVD, control
IGF - IMMULITE - CTL - 2x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385387
In Commercial Distribution

  • 00630414953212 ()
LGCOCM

  • Insulin-like growth factor I (IGF1) IVD, control
IGF-1-RIA-CT
Diasource Immunoassays S.A. SA
KIP1588
In Commercial Distribution

  • 05400569000520 ()


  • Insulin-like growth factor I (IGF1) IVD, kit, radioimmunoassay
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012568 ()
LCT1W30

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012537 ()
LAT1HD

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012520 ()
LATM20X5

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012513 ()
LATM10X5

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012483 ()
LAT1240

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012469 ()
LAT140X2

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011523 ()
FL-NC

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011516 ()
FL2-PC

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011325 ()
FL2SP

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011295 ()
FL2-30

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011288 ()
FL1-30

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011271 ()
FL12-60

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

  • 00812117010199 ()
LS1AEX01

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018638 ()
LATM10X5P

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018621 ()
LATM10SA

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018560 ()
LAT1HDS

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018553 ()
LAT140S

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018546 ()
LAT1288S

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018539 ()
LAT1240S

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018522 ()
LAT124010

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018164 ()
FL130BDS

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018157 ()
FL130-SAM

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018140 ()
FL1260SAM

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018133 ()
FL1-30-BD

  • 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

  • 00812117015859 ()
LSMUTR

  • 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

  • 00812117015231 ()
LS-AB2

  • 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

  • 00812117015224 ()
LS-NC

  • HLA class I & II antibody screening IVD, kit, multiplex
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015170 ()
LCT1W72

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

  • 00812117014654 ()
LS2AEX01

  • HLA class I & II antibody screening IVD, kit, multiplex
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012582 ()
LCT1W60

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