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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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LA 1 Screening Reagent - 00842768007477

LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10461887
In Commercial Distribution

  • 00842768007477 ()
  • 00842768019654 ()
OQGP15

  • Lupus anticoagulant marker IVD, reagent

N/T Rheumatology Control SL/2 - 00842768007279

Assayed control for RF ASL and CRP assays on Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446043
In Commercial Distribution

  • 00842768007279 ()
  • 00842768019081 ()
OQDC13

  • Rheumatoid factor IVD, control

N/T Rheumatology Control SL/1 - 00842768007262

Assayed control for RF, ASL and CRP assays on Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446041
In Commercial Distribution

  • 00842768007262 ()
  • 00842768019098 ()
OQDB13

  • Rheumatoid factor IVD, control

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

Imidazole Buffer Solution - 00842768007163

Imidazole Buffer Solution is used as diluent for various coagulation assays
Siemens Healthcare Diagnostics Products GmbH
10446032
In Commercial Distribution

  • 00842768007163 ()
  • 00842768019135 ()
OQAA33

  • Buffered sample diluent IVD

N Latex ASL - 00842768006807

Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445984
In Commercial Distribution

  • 00842768006807 ()
  • 00842768019241 ()
OPBU05

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

N Latex ASL - 00842768006791

Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445983
In Commercial Distribution

  • 00842768006791 ()
  • 00842768019258 ()
OPBU03

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

N Latex IgG4 - 00842768006692

Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445971
In Commercial Distribution

  • 00842768006692 ()
OPAU03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Protein 2 Control H - 00842768006487

PROT2 CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445937
In Commercial Distribution

  • 00842768006487 ()
  • 00842768019272 ()
KC787

  • Plasma protein IVD, control

DImension Vista® Protein 2 Control L - 00842768006470

PROT2 CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445936
In Commercial Distribution

  • 00842768006470 ()
  • 00842768019289 ()
KC785

  • Plasma protein IVD, control
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