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 Class Implantable

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HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control
HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
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
fPS Free PSA Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487239
In Commercial Distribution

  • 00630414977478 ()
L2KPF2(D)

  • Free (unbound) prostate specific antigen (fPSA) 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
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