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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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
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
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
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
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
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
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
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901873
In Commercial Distribution

  • 00630414167718 ()
L2KPW2(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay
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
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
IMMULITE 2000 Progesterone Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901874
In Commercial Distribution

  • 00630414167510 ()
L2KPW6(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Prolactin Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901869
In Commercial Distribution

  • 00630414167503 ()
L2KPR6(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Prolactin Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901868
In Commercial Distribution

  • 00630414167497 ()
L2KPR2(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 LH Kt Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901864
In Commercial Distribution

  • 00630414167480 ()
L2KLH6(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 LH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901863
In Commercial Distribution

  • 00630414167459 ()
L2KLH2(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 FSH Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901859
In Commercial Distribution

  • 00630414167442 ()
L2KFS6(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 FSH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901852
In Commercial Distribution

  • 00630414167435 ()
L2KFS2(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 DHEAS Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901849
In Commercial Distribution

  • 00630414167428 ()
L2KDS2(D)

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Crotisol Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901845
In Commercial Distribution

  • 00630414167411 ()
L2KCO6(D)

  • Total cortisol IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 Cortisol Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901844
In Commercial Distribution

  • 00630414167404 ()
L2KCO2(D)

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873571
In Commercial Distribution

  • 00630414023526 ()
B4233-17SY

  • Fibrinogen assay (factor I) IVD, kit, clotting
LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873570
In Commercial Distribution

  • 00630414023519 ()
  • 00842768019685 ()
OQWD13

  • Lupus anticoagulant marker IVD, control
LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873569
In Commercial Distribution

  • 00630414023502 ()
  • 00842768019678 ()
OQWE13

  • Lupus anticoagulant marker IVD, control
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873568
In Commercial Distribution

  • 00630414023496 ()
  • 00842768019609 ()
B4212-101

  • Prothrombin time (PT) IVD, reagent
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873567
In Commercial Distribution

  • 00630414023489 ()
  • 00842768019586 ()
B4212-51

  • Prothrombin time (PT) IVD, reagent
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873566
In Commercial Distribution

  • 00630414023472 ()
  • 00842768019593 ()
B4212-41

  • Prothrombin time (PT) IVD, reagent
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873565
In Commercial Distribution

  • 00630414023465 ()
  • 00842768018749 ()
OUHP53

  • Prothrombin time (PT) IVD, reagent
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873564
Not in Commercial Distribution

  • 00630414023441 ()
  • 00842768018756 ()
OUHP31

  • Prothrombin time (PT) IVD, kit, clotting
N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873692
In Commercial Distribution

  • 00630414285061 ()
  • 00630414287454 ()
OQIM19

  • Plasma protein IVD, calibrator
Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent
Quantitative determination of myoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873690
In Commercial Distribution

  • 00630414285047 ()
OWIA17

  • Myoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873689
In Commercial Distribution

  • 00630414285030 ()
OQAI15

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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
Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873687
In Commercial Distribution

  • 00630414287447 ()
  • 00630414285016 ()
OQCW07

  • Lipoprotein A IVD, control
Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator
Assayed control for RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873685
In Commercial Distribution

  • 00630414287423 ()
  • 00630414284996 ()
OQDC17

  • Rheumatoid factor IVD, control
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
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
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
Siemens Healthcare Diagnostics Products GmbH
10873675
In Commercial Distribution

  • 00630414240343 ()
OPPW05

  • Coagulation factor Xa inhibitor IVD, calibrator
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