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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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Coagulation Factor X Deficient Plasma - 00842768011030

For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446415
In Commercial Distribution

  • 00842768011030 ()
  • 00842768018817 ()
OTXY13

  • Coagulation factor X IVD, reagent

N Antiserum to Human Transferrin - 00842768009907

Quantitative determination of transferrin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446309
In Commercial Distribution

  • 00842768009907 ()
OSAX15

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

N Antiserum to Human a1-acid Glycoprotein - 00842768009884

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

N Latex ß2-Microglobulin - 00842768008429

Quantitative determination of ß2-microglobulin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446162
In Commercial Distribution

  • 00842768008429 ()
OQWU21

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

LA Control High - 00842768008351

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA 1 Screening Reagent (DRVVT) and LA 2 Confirmation Reagent (DRVVT) from Siemens Healthcare Diagnostics on automated coagulation analyzers
Siemens Healthcare Diagnostics Products GmbH
10446153
Not in Commercial Distribution

  • 00842768008351 ()
  • 00842768019685 ()
OQWD11

  • Multiple coagulation factor IVD, control

Cleaner SCS - 00842768008153

Cleaning solution BN II, BN ProSpec® Systems and BCS® Systems
Siemens Healthcare Diagnostics Products GmbH
10446136
In Commercial Distribution

  • 00842768008153 ()
  • 00842768018930 ()
OQUB21

  • Wash/cleaning solution IVD, automated/semi-automated system

N Latex IgE mono - 00842768008078

Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

N Supplementary Reagent L - 00842768008061

Supplementary reagent for multiple protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446128
In Commercial Distribution

  • 00842768008061 ()
OQTD11

  • Immunoglobulin removal reagent IVD

N Latex sTfR - 00842768008054

Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446127
In Commercial Distribution

  • 00842768008054 ()
  • 00842768018954 ()
OQTC11

  • Soluble transferrin receptor IVD, reagent

Neodisher® GK - 00842768008009

Cleaning agent for laboratory use
Siemens Healthcare Diagnostics Products GmbH
10446123
In Commercial Distribution

  • 00842768008009 ()
OQRK51

  • Wash/cleaning solution IVD, manual equipment

N/T Protein Control LC - 00842768007859

Assayed control for IgG, IgA, Transferrin, Albumin, a1-microglobulin and Total protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446105
In Commercial Distribution

  • 00842768007859 ()
  • 00842768018961 ()
OQLW15

  • Plasma protein IVD, control

N Antiserum to Human C1-Inhibitor - 00842768007323

Quantitative determination of C1 Inhibitor in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446049
In Commercial Distribution

  • 00842768007323 ()
OQEY09

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry

N Lp(a) Control SY - 00842768007248

Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446040
In Commercial Distribution

  • 00842768007248 ()
  • 00842768019104 ()
OQCW05

  • Lipoprotein A IVD, control

N Latex IgM - 00842768007194

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

Berichrom® Heparin LMW Control 1 - 00842768006876

For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445990
Not in Commercial Distribution

  • 00842768006876 ()
  • 00842768019180 ()
OPCD03

  • Multiple coagulation factor IVD, control

DImension Vista® C1 Inhibitor Calibrator - 00842768006401

For the calibration of the C1IN method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445926
Not in Commercial Distribution

  • 00842768006401 ()
  • 00842768019357 ()
KC740

  • Plasma protein IVD, calibrator

DImension Vista® Cystatin C Control L (low) - 00842768006388

CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445924
In Commercial Distribution

  • 00842768006388 ()
  • 00842768019371 ()
KC735

  • Plasma protein IVD, control

DImension Vista® Apolipoprotein Calibrator - 00842768006364

For the calibration of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445922
In Commercial Distribution

  • 00842768006364 ()
  • 00842768019395 ()
KC720

  • Plasma protein IVD, calibrator

DImension Vista® Protein 1 Control M (medium) - 00842768006340

PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445920
In Commercial Distribution

  • 00842768006340 ()
  • 00842768019425 ()
KC716

  • Plasma protein IVD, control

DImension Vista® C1 Inhibitor Flex® Reagent Cartridge - 00842768006302

For the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445915
Not in Commercial Distribution

  • 00842768006302 ()
  • 00842768020247 ()
K7086

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge - 00842768006289

For the quantitative measurement of immunoglobulin G subclass 3 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445913
In Commercial Distribution

  • 00842768006289 ()
  • 00842768020209 ()
K7082

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Transferrin Flex® reagent cartridge - 00842768006258

For the quantitative measurement of transferrin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445910
In Commercial Distribution

  • 00842768006258 ()
  • 00842768020179 ()
K7072

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Dimension Vista® Soluble Transferrin Receptor Flex® reagent cartridge - 00842768006241

For the quantitative measurement of soluble transferrin receptor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445909
In Commercial Distribution

  • 00842768006241 ()
  • 00842768020162 ()
K7070

  • Soluble transferrin receptor IVD, reagent

Dimension Vista® Rheumatoid Factors Flex® reagent cartridge - 00842768006234

For the quantitative measurement of rheumatoid factor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445908
In Commercial Distribution

  • 00842768006234 ()
  • 00842768020155 ()
K7068

  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry

DImension Vista® Retinol binding Protein - 00842768006227

For the quantitative measurement of retinol binding protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445907
Not in Commercial Distribution

  • 00842768006227 ()
  • 00842768020148 ()
K7066

  • Retinol binding protein IVD, kit, nephelometry/turbidimetry

DImension Vista® Prealbumin Flex® reagent cartridge - 00842768006210

For the quantitative measurement of Prealbumin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445906
In Commercial Distribution

  • 00842768006210 ()
  • 00842768020131 ()
K7064

  • Collagen pyridium crosslink IVD, reagent

DImension Vista® Microalbumin Flex® reagent cartridge - 00842768006203

For the quantitative measurement of albumin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445905
In Commercial Distribution

  • 00842768006203 ()
  • 00842768020124 ()
K7062

  • Albumin IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin M Flex® reagent cartridge - 00842768006197

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

DImension Vista® Immunoglobulin G Flex® reagent cartridge - 00842768006180

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

DImension Vista® Immunoglobulin E Flex® reagent cartridge - 00842768006173

For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445902
In Commercial Distribution

  • 00842768006173 ()
  • 00842768020087 ()
K7054

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin A Flex® reagent cartridge - 00842768006166

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

Dimension Vista hsCRP Flex reagent cartridge - 00842768006135

For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445898
In Commercial Distribution

  • 00842768006135 ()
  • 00842768020049 ()
K7046

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

DImension Vista® Homocysteine Flex® reagent cartridge - 00842768006128

For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445897
In Commercial Distribution

  • 00842768006128 ()
  • 00842768020032 ()
K7044

  • Homocysteine IVD, reagent

DImension Vista® Haptoglobin Flex® reagent cartridge - 00842768006111

For the quantitative measurement of haptoglobin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445896
In Commercial Distribution

  • 00842768006111 ()
  • 00842768020025 ()
K7042

  • Haptoglobin IVD, kit, nephelometry/turbidimetry

DImension Vista® Cystatin C Flex® reagent cartridge - 00842768006104

For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445895
In Commercial Distribution

  • 00842768006104 ()
  • 00842768020001 ()
K7040

  • Cystatin C IVD, kit, nephelometry/turbidimetry

DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin - 00842768006098

For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445894
In Commercial Distribution

  • 00842768006098 ()
  • 00842768019999 ()
K7034

  • Albumin IVD, kit, nephelometry/turbidimetry

Dimension Vista® C-Reactive Protein Flex® reagent cartridge - 00842768006081

For the quantitative measurement of C-reactive protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445893
In Commercial Distribution

  • 00842768006081 ()
  • 00842768019982 ()
K7032

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Ceruloplasmin Flex® reagent cartridge - 00842768006074

For the quantitative measurement of ceruloplasmin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445892
In Commercial Distribution

  • 00842768006074 ()
  • 00842768019975 ()
K7030

  • Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Dimension Vista® C4 Complement Flex® reagent cartridge - 00842768006067

For the quantitative measurement of C4 complement in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445891
In Commercial Distribution

  • 00842768006067 ()
  • 00842768019968 ()
K7028

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Dimension Vista® C3 Complement Flex® reagent cartridge - 00842768006050

For the quantitative measurement of C3 complement in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445890
In Commercial Distribution

  • 00842768006050 ()
  • 00842768019951 ()
K7026

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Dimension Vista® ß2-Microglobulin Flex® reagent cartridge - 00842768006043

For the quantitative measurement of ß2-microglobulin in human serum, plasma and urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445889
In Commercial Distribution

  • 00842768006043 ()
K7024

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista®Antistreptolysin O Flex® reagent cartridge - 00842768006036

For the quantitative measurement of antistreptolysin O in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445888
In Commercial Distribution

  • 00842768006036 ()
  • 00842768019944 ()
K7022

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Dimension Vista®Apolipoprotein B Flex® reagent cartridge - 00842768006029

For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445887
In Commercial Distribution

  • 00842768006029 ()
  • 00842768019906 ()
K7020

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista®a1-Antitrypsin Flex® reagent cartridge - 00842768005992

For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445884
In Commercial Distribution

  • 00842768005992 ()
  • 00842768019876 ()
K7014

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge - 00842768005985

For the quantitative measurement of a1-acid glycoprotein (Orosomucoid) in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445883
In Commercial Distribution

  • 00842768005985 ()
  • 00842768019869 ()
K7012

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Microglobulin Flex® reagent cartridge - 00842768005978

For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445882
Not in Commercial Distribution

  • 00842768005978 ()
  • 00842768019852 ()
K7010

  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry

Dade® Actin® FSL Activated PTT Reagent - 00842768003882

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445714
In Commercial Distribution

  • 00842768003882 ()
  • 00842768019555 ()
B4219-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003868

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445712
In Commercial Distribution

  • 00842768003868 ()
  • 00842768019562 ()
B4218-20

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003844

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445710
In Commercial Distribution

  • 00842768003844 ()
  • 00842768019562 ()
B4218-100

  • Activated partial thromboplastin time (APTT) IVD, reagent
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