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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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
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
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
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
IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
Strawberry -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385827
In Commercial Distribution

  • 00630414960142 ()
F44L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Salmon-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385825
In Commercial Distribution

  • 00630414960135 ()
F41L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Codfish -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385815
In Commercial Distribution

  • 00630414960111 ()
F3L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Potato -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385809
In Commercial Distribution

  • 00630414960104 ()
F35L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Orange -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385803
In Commercial Distribution

  • 00630414960098 ()
F33L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Carrot -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385797
In Commercial Distribution

  • 00630414960081 ()
F31L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Pinto Beans-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385785
In Commercial Distribution

  • 00630414960067 ()
F300L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Milk -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385784
In Commercial Distribution

  • 00630414960050 ()
F2L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Black Pepper-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385771
In Commercial Distribution

  • 00630414960043 ()
F280L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Beef -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385770
In Commercial Distribution

  • 00630414960036 ()
F27L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tomato -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385753
In Commercial Distribution

  • 00630414960012 ()
F25L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Grape-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385751
In Commercial Distribution

  • 00630414960005 ()
F259L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Walnut -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385749
In Commercial Distribution

  • 00630414959993 ()
F256L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Egg-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385742
In Commercial Distribution

  • 00630414959986 ()
F245L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Mushroom-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385716
In Commercial Distribution

  • 00630414959962 ()
F212L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Pistachio-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385707
In Commercial Distribution

  • 00630414959955 ()
F203L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Egg White -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385704
In Commercial Distribution

  • 00630414959948 ()
F1L4

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