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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Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Estriol unconjugated - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381168
Not in Commercial Distribution

  • 00630414984452 ()
LKUE31

  • Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
Allergen-Specific IgE - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708840
In Commercial Distribution

  • 00630414982939 ()
L2KUN6(D)

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Native Ole e 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370467
In Commercial Distribution

  • 00630414982915 ()
A482L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
MULTI DILUENT 2 - IMMULITE - CONS - 1x55mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708432
In Commercial Distribution

  • 00630414982304 ()
L2M2Z4(D)

  • Buffered sample diluent IVD
MULTI DILUENT 2 - IMMULITE - CONS - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708431
In Commercial Distribution

  • 00630414982298 ()
L2M2Z(D)

  • Buffered sample diluent IVD
sPS Third Generation PSA Control Module
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708295
In Commercial Distribution

  • 00630414982281 ()
  • 00630414601793 ()
LUPCM(D)

  • Total prostate specific antigen (tPSA) IVD, control
3PS Third Generation PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706293
Not in Commercial Distribution

  • 00630414982267 ()
LK3PS1(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
PTS PSA Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706282
In Commercial Distribution

  • 00630414982229 ()
L2KPTS6(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
PTS PSA Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706281
In Commercial Distribution

  • 00630414982212 ()
L2KPTS2(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
PTS PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706279
Not in Commercial Distribution

  • 00630414982205 ()
LKPTS1(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
aBs Anti-HBs Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10483780
In Commercial Distribution

  • 00630414982182 ()
L2KAB2(D)

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Allergen Specific IgE CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388502
In Commercial Distribution

  • 00630414979519 ()
L2UNCVM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
Testosterone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388170
In Commercial Distribution

  • 00630414979465 ()
LTWCVM

  • Total testosterone IVD, control
TSH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388157
In Commercial Distribution

  • 00630414979458 ()
LTSCVM

  • Thyroid stimulating hormone (TSH) IVD, control
Prolactin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388107
In Commercial Distribution

  • 00630414979427 ()
LPRCVM

  • Prolactin IVD, control
PTH Intact CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388105
In Commercial Distribution

  • 00630414979410 ()
LPPCVM

  • Parathyroid hormone (PTH) IVD, control
Ferritin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387969
In Commercial Distribution

  • 00630414979403 ()
LFECVM

  • Ferritin IVD, control
HCG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387935
In Commercial Distribution

  • 00630414979373 ()
LDSCVM

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
ACTH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387863
In Commercial Distribution

  • 00630414979366 ()
LACCVM

  • Adrenocorticotropic hormone (ACTH) IVD, control
Baccharis -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386159
In Commercial Distribution

  • 00630414979212 ()
W67L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dog Fennel-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386156
In Commercial Distribution

  • 00630414979205 ()
W46L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Common Sagebrush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386155
In Commercial Distribution

  • 00630414979199 ()
W43L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Saltbush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386153
In Commercial Distribution

  • 00630414979182 ()
W37L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Rabbit Bush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386152
In Commercial Distribution

  • 00630414979175 ()
W36L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Firebush -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386138
In Commercial Distribution

  • 00630414979144 ()
W17L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Rough Marsh Elder -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386137
In Commercial Distribution

  • 00630414979137 ()
W16L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Scale -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386136
In Commercial Distribution

  • 00630414979120 ()
W15L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Rough Pigweed -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386135
In Commercial Distribution

  • 00630414979113 ()
W14L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Goldenrod -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386133
In Commercial Distribution

  • 00630414979106 ()
W12L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Queen Palm -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386103
In Commercial Distribution

  • 00630414979076 ()
T72L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Red Mulberry-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386102
In Commercial Distribution

  • 00630414979069 ()
T71L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Loblolly Pine-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386094
In Commercial Distribution

  • 00630414979038 ()
T43L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
White Hickory-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386092
In Commercial Distribution

  • 00630414979021 ()
T41L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Brazilian Peppertree-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386088
In Commercial Distribution

  • 00630414978994 ()
T401L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
White Bald Cypress-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386085
In Commercial Distribution

  • 00630414978987 ()
T37L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Locust Tree-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386081
In Commercial Distribution

  • 00630414978963 ()
T280L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Red Maple-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386080
In Commercial Distribution

  • 00630414978956 ()
T27L2

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