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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Native Bet v 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368597
In Commercial Distribution

  • 00630414988122 ()
A89L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Progesterone Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388207
In Commercial Distribution

  • 00630414986319 ()
LPWZ

  • Buffered sample diluent IVD
Progesterone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10638189
In Commercial Distribution

  • 00630414986159 ()
LPWCVM(D)

  • Progesterone IVD, control
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10642239
In Commercial Distribution

  • 00630414986098 ()
L2KTI2(D)

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10642238
Not in Commercial Distribution

  • 00630414986081 ()
LSKTI1(D)

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10642237
In Commercial Distribution

  • 00630414986074 ()
LKTI1(D)

  • Troponin I IVD, kit, chemiluminescent immunoassay
Progesterone - IMMULITE - RGT - 100 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381128
In Commercial Distribution

  • 00630414985732 ()
LKPW1

  • Progesterone IVD, kit, chemiluminescent immunoassay
CMV IgM Ab - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370302
In Commercial Distribution

  • 00630414985725 ()
L2KCM2(D)

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems CMV IgM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370301
In Commercial Distribution

  • 00630414985718 ()
LKCM1(D)

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Specific IgE Neg - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485107
In Commercial Distribution

  • 00630414984599 ()
L2SNCCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Specific IgE M6 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485106
In Commercial Distribution

  • 00630414984582 ()
MC6LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
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
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
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
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
T4 Total - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381685
In Commercial Distribution

  • 00630414972992 ()
L2KT42

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Oregano-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385773
In Commercial Distribution

  • 00630414972503 ()
F283L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems Rubella IgM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374044
Not in Commercial Distribution

  • 00630414971582 ()
LKRM1(D)

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
fPS Free PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374043
In Commercial Distribution

  • 00630414971575 ()
LKPF1(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
HBS HBsAg Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374038
Not in Commercial Distribution

  • 00630414971551 ()
LKHB1(D)

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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
HBS HBsAg Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374014
In Commercial Distribution

  • 00630414971438 ()
L2KHB2(D)

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Vitamin B12 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373710
In Commercial Distribution

  • 00630414971421 ()
LVBCVM

  • Vitamin B12 IVD, control
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