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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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Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56100 ()
BSB 5610

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
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
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
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (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
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
No Description
Bion Enterprises, Ltd.
P1-7112
Not in Commercial Distribution

  • B110P171120 ()
P1-7112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
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