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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 DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1561
In Commercial Distribution

  • 04048474015614 ()
EIA-1561

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).
Aesku.Diagnostics GmbH & Co. KG
7215US
In Commercial Distribution

  • 04250289503099 ()
7215US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).
Aesku.Diagnostics GmbH & Co. KG
7206US
In Commercial Distribution

  • 04250289503082 ()
7206US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
Aesku.Diagnostics GmbH & Co. KG
7205US
In Commercial Distribution

  • 04250289503075 ()
7205US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). 30'+30'+30' automation incubation.
Aesku.Diagnostics GmbH & Co. KG
30-7215US
In Commercial Distribution

  • 04250289502849 ()
30-7215US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). 30'+30'+30' automation incubation.
Aesku.Diagnostics GmbH & Co. KG
30-7206US
In Commercial Distribution

  • 04250289502832 ()
30-7206US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation.
Aesku.Diagnostics GmbH & Co. KG
30-7205US
In Commercial Distribution

  • 04250289502825 ()
30-7205US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).
Aesku.Diagnostics GmbH & Co. KG
3215
In Commercial Distribution

  • 04250289500951 ()


  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).
Aesku.Diagnostics GmbH & Co. KG
3206
In Commercial Distribution

  • 04250289500869 ()


  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome.
Aesku.Diagnostics GmbH & Co. KG
3205
In Commercial Distribution

  • 04250289500852 ()


  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
For Use with Factor VIII Antibody Screen and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403622
In Commercial Distribution

  • 10888234500407 ()
403622

  • HLA class I antibody screening IVD, reagent
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
DSI+II
In Commercial Distribution

  • 10888234500193 ()
DSI+II

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
303456
In Commercial Distribution

  • 10888234500186 ()
303456

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin-like Growth Factor 1, IGF-1, in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4140
Not in Commercial Distribution

  • 00404847441406 ()
EIA-4140

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1561
Not in Commercial Distribution

  • 00404847415612 ()
EIA-1561

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
for 24 determinations of HLA-ABC alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826240
Not in Commercial Distribution

  • 07611969953318 ()
826240

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
Kit for 24 determinations of HLA-C alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826212
Not in Commercial Distribution

  • 07611969953271 ()
826212

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
for 24 determinations of HLA-B alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826206
Not in Commercial Distribution

  • 07611969953264 ()
826206

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
for 24 determinations of HLA-A alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826201
Not in Commercial Distribution

  • 07611969953257 ()
826201

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
No Description
Euro-Diagnostica AB
FBGP100
In Commercial Distribution

  • 07340058410158 ()
FBGP100

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Euro-Diagnostica AB
FBGP200
In Commercial Distribution

  • 07340058410141 ()
FBGP200

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07475969190
In Commercial Distribution

  • 07613336143148 ()
07475969190

  • Insulin-like growth factor I (IGF1) IVD, calibrator
No Description
Roche Diagnostics GmbH
07475896190
In Commercial Distribution

  • 07613336143131 ()
07475896190

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07475918190
In Commercial Distribution

  • 07613336140864 ()
07475918190

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
For Use with DonorScreen-HLA Class I and Class II
IMMUCOR GTI DIAGNOSTICS, INC.
404563
In Commercial Distribution

  • 10888234500483 ()
404563

  • HLA class I & II antibody screening IVD, reagent
for 24 determinations of HLA-ABDR alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826230
Not in Commercial Distribution

  • 07611969953301 ()
826230

  • HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
BED ONLY,4-MOTOR,HI/LOW,34.5"W,LOCK
MEDLINE INDUSTRIES, INC.
FCE1385B
In Commercial Distribution

  • 10888277100022 ()
FCE1385B

  • Basic electric hospital bed
For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628201
In Commercial Distribution

  • 10888234400561 ()
628201

  • HLA class I & II antigen tissue typing IVD, reagent
For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628212
In Commercial Distribution

  • 10888234400509 ()
628212

  • HLA class I & II antigen tissue typing IVD, reagent
No Description
BIOCARE MEDICAL LLC
AVI3289G
In Commercial Distribution

  • 00847627032249 ()


  • HLA class I antigen non-tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3289G7
In Commercial Distribution

  • 00847627032232 ()


  • HLA class I antigen non-tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3289T60
In Commercial Distribution

  • 00847627032225 ()


  • HLA class I antigen non-tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3289AA
In Commercial Distribution

  • 00847627032218 ()


  • HLA class I antigen non-tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3289C
In Commercial Distribution

  • 00847627032201 ()


  • HLA class I antigen non-tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3289A
In Commercial Distribution

  • 00847627032195 ()


  • HLA class I antigen non-tissue typing IVD, antibody
UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentration of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum.
Aidian Oy
67034
In Commercial Distribution

  • 06438115000082 ()
67034

  • Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay
The PG3101 Detection Reagent is used for amplification of the HLA-A*3101 allele.
PHARMIGENE, Inc.
PG-3101A-024
In Commercial Distribution

  • 04719872780717 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG5801 Detection Reagent is used for amplification of the HLA-B*5801 allele.
PHARMIGENE, Inc.
PG-5801A-024
In Commercial Distribution

  • 04719872780441 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG0602 Detection Reagent is used for amplification of the HLA-DQB1*0602 allele.
PHARMIGENE, Inc.
PG-0602A-024
In Commercial Distribution

  • 04719872782278 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG5101 Detection Reagent is used for amplification of the HLA-B*5101 allele.
PHARMIGENE, Inc.
PG-5101A-024
In Commercial Distribution

  • 04719872782254 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
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