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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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No Description
Roche Diagnostics GmbH
07027508190
In Commercial Distribution

  • 04015630940448 ()
07027508190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07027494190
In Commercial Distribution

  • 04015630940431 ()
07027494190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
For the detection and titration of HSV-2 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902601
In Commercial Distribution

  • G5229026011 ()


  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of HSV-2 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902600
In Commercial Distribution

  • G522902600 ()


  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
DIASORIN MOLECULAR LLC
IB0900G
In Commercial Distribution

  • 20816101021004 ()
IB0900G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.
Gold Standard Diagnostics Corporation
720-340
In Commercial Distribution

  • B3507203400 ()
720-340

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69058
In Commercial Distribution

  • 15099590742751 ()
C69058

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6530
In Commercial Distribution

  • 05060169695979 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
Captia™ Chlamydia IgG
CLARK LABORATORIES, INC.
2346200
In Commercial Distribution

  • 05391516743952 ()

  • 96 Tests
2346200

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P3-9112
Not in Commercial Distribution

  • B110P391120 ()
P3-9112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P2-8112
Not in Commercial Distribution

  • B110P281120 ()
P2-8112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P1-7112
Not in Commercial Distribution

  • B110P171120 ()
P1-7112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
AALTO SCIENTIFIC
K087M-6
In Commercial Distribution

  • B085K087M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
AALTO SCIENTIFIC
K077M-6
In Commercial Distribution

  • B085K077M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
ID Candida Antibody System
Immuno-Mycologics, Inc.
CA1001
In Commercial Distribution

  • 00816387020797 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent
Candida ID Positive Control
Immuno-Mycologics, Inc.
C60110
In Commercial Distribution

  • 00816387020230 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent
Candida ID Antigen
Immuno-Mycologics, Inc.
C50110
In Commercial Distribution

  • 00816387020223 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5645
In Commercial Distribution

  • 04048474056457 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5645
In Commercial Distribution

  • 00840239056450 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control
EliA SARS-CoV-2-Sp1 IgG Well
Phadia AB
DECC066630
In Commercial Distribution

  • 07333066021201 ()
  • 07333066021287 ()
DECC066630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Syphilis IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865010924 ()

  • 1 Each
6651470E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, Syphilis IgG IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865006682 ()

  • 1 Each
6651460F

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Syphilis IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002233 ()

  • 1 Each
6651470D

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, BioPlex 2200, Syphilis IgG IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002134 ()

  • 1 Each
6651460E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Syphilis IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651450
In Commercial Distribution

  • 00847865000307 ()

  • 1 Tests
6651450

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Sample Diluent/Wash Powder , 5g
MARDX DIAGNOSTICS, INC.
40-2030
In Commercial Distribution

  • 05391516749152 ()
40-2030

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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