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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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
Solution for preparing dilutions for immunochemical determinations with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446457
In Commercial Distribution

  • 00842768011436 ()
OUMT65

  • Buffered sample diluent IVD
Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Quantitative determination of plasminogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446314
In Commercial Distribution

  • 00842768009952 ()
OSCB09

  • Plasminogen IVD, reagent
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 IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446299
In Commercial Distribution

  • 00842768009808 ()
OSAS19

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446297
In Commercial Distribution

  • 00842768009785 ()
OSAS11

  • Total immunoglobulin G (IgG 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
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 G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445903
In Commercial Distribution

  • 00842768006180 ()
  • 00842768020094 ()
K7056

  • Total immunoglobulin G (IgG 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
Reaction medium for immunochemical determination with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446455
In Commercial Distribution

  • 00842768014246 ()
OUMS65

  • Multiple clinical chemistry protein IVD, reagent
Pierceable Heat Seals for 96 Well Plates Vitamins A and E in serum/plasma, Automated with 96 well filter plates
Chromsystems Instruments + Chemicals GmbH
34760
In Commercial Distribution

  • 04250317537058 ()

  • 6 pcs.
34760

  • Microplate IVD
HPLC Reagent Kit, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
Chromsystems Instruments + Chemicals GmbH
34700/F
In Commercial Distribution

  • 04250317532770 ()

  • 5 x 96 analyses
34700/F

  • Multiple vitamin IVD, kit, liquid chromatography
UHPLC Reagent Kit, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
Chromsystems Instruments + Chemicals GmbH
34900/F
In Commercial Distribution

  • 04250317532749 ()

  • 10 x 96 analyses
34900/F

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, One Step Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34000/PREMIX
In Commercial Distribution

  • 04250317532671 ()

  • 100 analyses
34000/PREMIX

  • Multiple vitamin IVD, kit, liquid chromatography
UHPLC One Step Reagent Kit, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34900/UHPLC
In Commercial Distribution

  • 04250317532046 ()

  • 1000 analyses
34900/UHPLC

  • Multiple vitamin IVD, kit, liquid chromatography
96 Well Collection Plates for automated sample preparation, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34758
In Commercial Distribution

  • 04250317526847 ()

  • 5 pcs.
34758

  • Microplate IVD
96 Well Filter Plates for automated sample preparation, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34757
In Commercial Distribution

  • 04250317526830 ()

  • 5 pcs.
34757

  • Microplate IVD
Internal Standard, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
Chromsystems Instruments + Chemicals GmbH
34708
In Commercial Distribution

  • 04250317526823 ()

  • 100 ml
34708

  • Multiple vitamin IVD, reagent
Pre-mixed Reaction Tubes, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34906
In Commercial Distribution

  • 04250317526779 ()

  • 100 pcs.
34906

  • Multiple vitamin IVD, reagent
Internal Standard, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34008
In Commercial Distribution

  • 04250317506092 ()

  • 2 ml
34008

  • Multiple vitamin IVD, reagent
Precipitation Reagent I, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34006
In Commercial Distribution

  • 04250317506078 ()

  • 2.5 ml
34006

  • Multiple vitamin IVD, reagent
Precipitation Reagent II, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34003
In Commercial Distribution

  • 04250317506030 ()

  • 40 ml
34003

  • Multiple vitamin IVD, reagent
Mobile Phase, Vitamins A and E in serum/plasma 10x1000mL
Chromsystems Instruments + Chemicals GmbH
34002
In Commercial Distribution

  • 04250317506023 ()

  • 10 x 1000ml
34002

  • Multiple vitamin IVD, reagent
Mobile Phase, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34001
In Commercial Distribution

  • 04250317505996 ()

  • 1000 ml
34001

  • Multiple vitamin IVD, reagent
HPLC Reagent Kit, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34000
In Commercial Distribution

  • 04250317505958 ()

  • 100 analyses
34000

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, ß-Carotene in serum/plasma
Chromsystems Instruments + Chemicals GmbH
32000
In Commercial Distribution

  • 04250317505743 ()

  • 100 analyses
32000

  • Vitamin A IVD, kit, spectrophotometry
HPLC Basic Kit, Vitamins A and E in serum/plasma, with 96 Deep Well Plates
Chromsystems Instruments + Chemicals GmbH
34400-DWP-BK
In Commercial Distribution

  • 04250317554789 ()

  • 200 analyses
34400-DWP-BK

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, Vitamins A and E in serum/plasma, with 96 Deep Well Plates
Chromsystems Instruments + Chemicals GmbH
34400-DWP
In Commercial Distribution

  • 04250317554772 ()

  • 200 analyses
34400-DWP

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Basic Kit, Vitamins A and E in serum/plasma with Reaction Vials
Chromsystems Instruments + Chemicals GmbH
34400-BK
In Commercial Distribution

  • 04250317554765 ()

  • 200 analyses
34400-BK

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34400
In Commercial Distribution

  • 04250317554758 ()

  • 200 analyses
34400

  • Multiple vitamin IVD, kit, liquid chromatography
Cross-slitted Adhesive Seals for 96 well plates, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34459
In Commercial Distribution

  • 04250317553447 ()

  • 3 pcs.
34459

  • Microplate IVD
96 Deep Well Plates, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34456
In Commercial Distribution

  • 04250317553430 ()

  • 6 pcs.
34456

  • Microplate IVD
Internal Standard, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34404
In Commercial Distribution

  • 04250317552884 ()

  • 40 ml
34404

  • Multiple vitamin IVD, reagent
Precipitation Reagent, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34405
In Commercial Distribution

  • 04250317552877 ()

  • 40 ml
34405

  • Multiple vitamin IVD, reagent
UHPLC Reagent Kit, One Step Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34934/UHPLC
In Commercial Distribution

  • 04250317550712 ()

  • 1000 analyses
34934/UHPLC

  • Multiple vitamin IVD, kit, liquid chromatography
Pre-mixed Solution
Chromsystems Instruments + Chemicals GmbH
34966
In Commercial Distribution

  • 04250317550705 ()

  • 20 ml
34966

  • Multiple vitamin IVD, reagent
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