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

  • 00630414000138 ()
A127L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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
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
IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
rPru av 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471072
In Commercial Distribution

  • 00630414006345 ()
A597L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rMal d 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471077
In Commercial Distribution

  • 00630414006291 ()
A796L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
nPru p 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368596
In Commercial Distribution

  • 00630414006284 ()
A603L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rPru av 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471075
In Commercial Distribution

  • 00630414006277 ()
A600L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rPru av 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471074
In Commercial Distribution

  • 00630414006253 ()
A599L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
rMal d 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10483381
In Commercial Distribution

  • 00630414006246 ()
A464L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
11254820
In Commercial Distribution

  • 00630414002903 ()
OVIA112

  • Nephelometry immunoassay analyser IVD
Growth Hormone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128533
In Commercial Distribution

  • 00630414000213 ()
LGRHCVM

  • Human growth hormone (HGH) IVD, control
Cat Dander Epithelium-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385642
In Commercial Distribution

  • 00630414959696 ()
E1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Acarus siro-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385635
In Commercial Distribution

  • 00630414959672 ()
D70L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dermatophagoides microceras-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385634
In Commercial Distribution

  • 00630414959665 ()
D3L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dermatophagoides farinae-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385633
In Commercial Distribution

  • 00630414959658 ()
D2L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385630
In Commercial Distribution

  • 00630414959641 ()
D1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381639
In Commercial Distribution

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent
Folic/B12 Common Sample - IMMULITE - CONS - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387054
In Commercial Distribution

  • 00630414954455 ()
L2FVZ

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control
Vitamin B12 Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386999
In Commercial Distribution

  • 00630414954448 ()
LVBZ

  • Buffered sample diluent IVD
TSH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387061
In Commercial Distribution

  • 00630414954417 ()
L2TSZ

  • Buffered sample diluent IVD
TSH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386996
In Commercial Distribution

  • 00630414954400 ()
LTSZ

  • Buffered sample diluent IVD
Troponin I Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386995
In Commercial Distribution

  • 00630414954394 ()
LTIZ

  • Buffered sample diluent IVD
Total T4 Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387587
In Commercial Distribution

  • 00630414954370 ()
LT4Z

  • Buffered sample diluent IVD
T3 Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387578
In Commercial Distribution

  • 00630414954363 ()
LT3Z

  • Buffered sample diluent IVD
IGE total - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386937
In Commercial Distribution

  • 00630414954356 ()
LIEZ

  • Buffered sample diluent IVD
TG Ab Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387073
In Commercial Distribution

  • 00630414954318 ()
L2TYZ

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control
Thyroglobulin Sample Diluent - IMMULITE -- 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387046
In Commercial Distribution

  • 00630414954301 ()
LTYZ

  • Buffered sample diluent IVD
TBG Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387072
In Commercial Distribution

  • 00630414954271 ()
L2TBZ

  • Buffered sample diluent IVD
SHBG SAMPLE DILUENT - IMMULITE 2000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387041
In Commercial Distribution

  • 00630414954226 ()
LSHZ

  • Buffered sample diluent IVD
Rapid TSH Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387486
In Commercial Distribution

  • 00630414954219 ()
LRTZ

  • Buffered sample diluent IVD
Pyrilink-D Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387038
In Commercial Distribution

  • 00630414954202 ()
LPDZ

  • Buffered sample diluent IVD
PSA Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386994
In Commercial Distribution

  • 00630414954196 ()
LPSZ

  • Buffered sample diluent IVD
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