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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HBsAg Confirmatory Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374036
Not in Commercial Distribution

  • 00630414971544 ()
LKCH(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Toxoplasma IgM Ab - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374023
In Commercial Distribution

  • 00630414971483 ()
L2KTM2(D)

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Rubella IgM Ab - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374021
In Commercial Distribution

  • 00630414971469 ()
L2KRM2(D)

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Vitamin B12 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373710
In Commercial Distribution

  • 00630414971421 ()
LVBCVM

  • Vitamin B12 IVD, control
Anti-TPO CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373708
In Commercial Distribution

  • 00630414971407 ()
LTOCVM

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
TG Ab CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373706
In Commercial Distribution

  • 00630414971384 ()
LTGCVM

  • Thyroglobulin antibody IVD, control
TBG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373705
In Commercial Distribution

  • 00630414971377 ()
LTBCVM

  • Thyroxine binding globulin (TBG) IVD, control
Free PSA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373702
In Commercial Distribution

  • 00630414971346 ()
LPFCVM

  • Free (unbound) prostate specific antigen (fPSA) IVD, control
Calcitonin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373685
In Commercial Distribution

  • 00630414971186 ()
LCLCVM

  • Procalcitonin (PCT) IVD, control
CEA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373684
In Commercial Distribution

  • 00630414971179 ()
LCECVM

  • Carcinoembryonic antigen (CEA) IVD, control
BR-MA - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373682
In Commercial Distribution

  • 00630414971155 ()
LBRCVM

  • Cancer antigen 15-3 (CA15-3) IVD, control
AFP CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373681
In Commercial Distribution

  • 00630414971148 ()
LAPCVM

  • Alpha-fetoprotein (AFP) IVD, control
aHB Anti-HBs Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10372452
Not in Commercial Distribution

  • 00630414970998 ()
LKAH1(D)

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
aBC Anti-HBc Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370306
In Commercial Distribution

  • 00630414970981 ()
L2KHC2(D)

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
aBC Anti-HBc Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370305
Not in Commercial Distribution

  • 00630414970974 ()
LKHC1(D)

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Stemphylium solani-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360577
In Commercial Distribution

  • 00630414970691 ()
M88L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Felis domesticus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360576
In Commercial Distribution

  • 00630414970684 ()
A345L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360575
In Commercial Distribution

  • 00630414970677 ()
A316L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
T4 Total - IMMULITE - RGT - 500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381635
Not in Commercial Distribution

  • 00630414970110 ()
LKT45

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Imported Fire Ant -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385960
In Commercial Distribution

  • 00630414965680 ()
I70L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Yellow Hornet -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385958
In Commercial Distribution

  • 00630414965673 ()
I5L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Cheese, Cheddar -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385858
In Commercial Distribution

  • 00630414965659 ()
F81L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Barley -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385845
In Commercial Distribution

  • 00630414965642 ()
F6L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tuna -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385824
In Commercial Distribution

  • 00630414965635 ()
F40L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Blue Mussel -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385812
In Commercial Distribution

  • 00630414965628 ()
F37L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Spinach-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385718
In Commercial Distribution

  • 00630414965598 ()
F214L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Weed Panel 3 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386174
In Commercial Distribution

  • 00630414965529 ()
WP3L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Lamb#s Quarters -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386131
In Commercial Distribution

  • 00630414965383 ()
W10L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 7 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386128
In Commercial Distribution

  • 00630414965369 ()
TP7L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 4 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386122
In Commercial Distribution

  • 00630414965338 ()
TP4L4

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