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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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IMMULITE®/IMMULITE® 1000 Systems IGF-I - 00630414601243

Insulin-like growth factor I (IGF-I) 100 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128584
In Commercial Distribution

  • 00630414601243 ()
LKIGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems IGF-I - 00630414601236

Insulin-like growth factor I (IGF-I) 200 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128543
In Commercial Distribution

  • 00630414601236 ()
L2KIGF2

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

BC von Willebrand Reagent - 00630414320366

Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10874080
In Commercial Distribution

  • 00842768018800 ()
  • 00630414320366 ()
10874080

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

IMMULITE 2000 Third Generation TSH - 00630414210841

TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129119
In Commercial Distribution

  • 00630414210841 ()
L2KTS6(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Third Generation TSH - 00630414210834

TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129118
In Commercial Distribution

  • 00630414210834 ()
L2KTS2(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

N Protein Standard UY - 00630414167848

Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873632
In Commercial Distribution

  • 00630414167848 ()
  • 00842768018978 ()
10873632

  • Plasma protein IVD, calibrator

N Latex Cystatin C - 00630414167824

Quantitative determination of cystatin C in human serum and lithium-heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873631
In Commercial Distribution

  • 00630414167824 ()
OQNM19

  • Cystatin C IVD, kit, nephelometry/turbidimetry

IMMULITE 2000 Progesterone Kit Domestic 200T - 00630414167718

IMMULITE 2000 Progesterone Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901873
In Commercial Distribution

  • 00630414167718 ()
L2KPW2(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay

N LATEX FLC lambda - 00630414167664

Quantitative determination of free light chains (FLC) type lambda in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10873630
In Commercial Distribution

  • 00630414167664 ()
  • 00630414229089 ()
OPJB07

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

N LATEX FLC KAPPA - 00630414167657

Quantitative determination of free light chains (FLC) type kappa in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10873629
In Commercial Distribution

  • 00630414167657 ()
  • 00630414229072 ()
OPJA075

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
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