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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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Quantitative determination of fibrinogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446313
In Commercial Distribution

  • 00842768009945 ()
OSCA09

  • Fibrinogen assay (factor I) IVD, kit, clotting
Quantitative determination of antithrombin III in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446310
In Commercial Distribution

  • 00842768009914 ()
OSAY09

  • Antithrombin III (ATIII) IVD, reagent
Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446307
In Commercial Distribution

  • 00842768009884 ()
OSAW15

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446306
In Commercial Distribution

  • 00842768009877 ()
OSAW09

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446305
In Commercial Distribution

  • 00842768009860 ()
OSAV15

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446304
In Commercial Distribution

  • 00842768009853 ()
OSAV09

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446303
In Commercial Distribution

  • 00842768009846 ()
OSAT19

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446301
In Commercial Distribution

  • 00842768009822 ()
OSAT11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446295
In Commercial Distribution

  • 00842768009761 ()
OSAR19

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446293
In Commercial Distribution

  • 00842768009747 ()
OSAR11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446287
In Commercial Distribution

  • 00842768009686 ()
OSAN15

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446286
In Commercial Distribution

  • 00842768009679 ()
OSAN09

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446035
In Commercial Distribution

  • 00842768007194 ()
OQAC11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10469513
In Commercial Distribution

  • 00842768030239 ()
  • 00842768020261 ()
OUMT05

  • Buffered sample diluent IVD
Supplementary reagent for multiple protein assays on Siemens systems
Siemens Healthcare Diagnostics Products GmbH
10446458
In Commercial Distribution

  • 00842768011443 ()
OUMU15

  • Buffered isotonic saline reagent IVD
For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Radial immunodiffusion plate package for Human C-3 (b1c/b1a) with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761055 ()
105511

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for Human C-3 (b1c/b1a)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761054 ()
105411

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for human IgM with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761035 ()
103511

  • Total immunoglobulin M (IgM total) IVD, antibody
Radial immunodiffusion plate package for human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B176103411 ()
103411

  • Total immunoglobulin M (IgM total) IVD, antibody
IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
Beckman Coulter, Inc.
446460
In Commercial Distribution

  • 15099590230470 ()
446460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
Beckman Coulter, Inc.
447460
In Commercial Distribution

  • 15099590221225 ()
447460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
447470
In Commercial Distribution

  • 15099590221218 ()
447470

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B-A
In Commercial Distribution

  • 05391516747967 ()
40-5065G/B-A

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
32-5010
In Commercial Distribution

  • 05391516747608 ()
32-5010

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Borrelia burgdorferi EIA IgG
CLARK LABORATORIES, INC.
40-8696G
In Commercial Distribution

  • 05391516746625 ()

  • 96 Tests
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi EIA (IgG) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696G
In Commercial Distribution

  • 05391516746267 ()
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B
In Commercial Distribution

  • 05391516746236 ()
40-5065G/B

  • Borrelia garinii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi (IgG) Marblot Strip Test System (50 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G
In Commercial Distribution

  • 05391516746229 ()
40-5065G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
B. burgdorferi (IgG) Marblot Strip Test System (20 Tests)
MARDX DIAGNOSTICS, INC.
40-2075G
In Commercial Distribution

  • 05391516746205 ()
40-2075G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
CAPTIA™ Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-960
In Commercial Distribution

  • 05391516744836 ()

  • 960 Tests
800-960

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
CAPTIA™Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-970
In Commercial Distribution

  • 05391516744829 ()

  • 96 Tests
800-970

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007609 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007043 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
IB0901
In Commercial Distribution

  • 10816101021014 ()
IB0901

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, reagent
The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
DRG International Inc
EIA-3474
In Commercial Distribution

  • 00840239034748 ()

  • Positive Control
  • Stop Solution
  • Chromogen TMB
  • Total Volume: 11 Milliliter
  • Total Volume: 1 Milliliter
  • Total Volume: 30 Milliliter
  • Enzyme Conjugate
  • Total Volume: 25 Milliliter
  • Negative Control
  • Wash Concentrate
  • Dilution Buffer
EIA-3474

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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