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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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BN ProSpec® System - 00630414002736

The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
10465217
In Commercial Distribution

  • 00630414002736 ()
OVLI012

  • Nephelometry immunoassay analyser IVD

IMMULITE® GROWTH HORMONE CVM - 00630414000213

Growth Hormone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128533
In Commercial Distribution

  • 00630414000213 ()
LGRHCVM

  • Human growth hormone (HGH) IVD, control

IMMULITE 2000 Systems Anti-CCP IgG Calibration Verification Material - 00630414000206

IMMULITE® 2000 Systems CCP Calibration Verification Material Anti-CCP IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10718363
In Commercial Distribution

  • 00630414000206 ()
L2PICVM(D)

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

IMMULITE 2000 rBet v 2 Specific Allergen - 00630414000138

rBet v 2 Alleren
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10484690
In Commercial Distribution

  • 00630414000138 ()
A127L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

N Latex IgM - 00630414285023

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873688
In Commercial Distribution

  • 00630414285023 ()
OQAC15

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

N LP(a) Standard SY - 00630414285009

Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator

N/T Rheumatology Control SL/1 - 00630414284989

Assayed control for RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873684
In Commercial Distribution

  • 00630414287416 ()
  • 00630414284989 ()
OQDB17

  • Rheumatoid factor IVD, control

N Rheumatology Standard SL - 00630414284972

Calibration of RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873683
In Commercial Distribution

  • 00630414287409 ()
  • 00630414284972 ()
OQKZ15

  • Rheumatoid factor IVD, calibrator

INNOVANCE Anti-Xa - 00630414240404

In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
Siemens Healthcare Diagnostics Products GmbH
10873681
In Commercial Distribution

  • 00630414240404 ()
OPPU05

  • Coagulation factor Xa inhibitor/heparin activity reagent kit IVD

INNOVANCE Apixaban Standards - 00630414240343

INNOVANCE Apixaban Standards
Siemens Healthcare Diagnostics Products GmbH
10873675
In Commercial Distribution

  • 00630414240343 ()
OPPW05

  • Coagulation factor Xa inhibitor IVD, calibrator
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