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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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JUVEDERM VOLLURE XC - 10888628034488

Juvéderm Vollure XC 30G 2x1.0mL
Allergan, Inc.
95661
In Commercial Distribution

  • 10888628034471 ()
  • 10888628034488 ()

  • 30G 2x1.0mL
95661

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

IMMULITE® 2000 Systems BcM Anti-HBc IgM - 00630414977737

BcM Anti-HBc IgM Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488616
In Commercial Distribution

  • 00630414977737 ()
L2KMC2(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE®1000 Systems BcM Anti-HBc IgM - 00630414977720

BcM Anti-HBc IgM Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488615
Not in Commercial Distribution

  • 00630414977720 ()
LKMC1(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems fPS Free PSA - 00630414977478

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

IMMULITE®/IMMULITE®1000 Systems AF AFP - 00630414963594

AF AFP Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381162
In Commercial Distribution

  • 00630414963594 ()
LKAP1

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems AF AFP - 00630414961040

AF AFP Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381184
In Commercial Distribution

  • 00630414961040 ()
L2KAP6

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems AF AFP - 00630414961033

AF AFP Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381187
In Commercial Distribution

  • 00630414961033 ()
L2KAP2

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

IMMULITE®1000 System ID4 ID4 Sample Diluent - 00630414960975

ID4 Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381266
In Commercial Distribution

  • 00630414960975 ()
  • 00630414601748 ()
L1KMCW1

  • Buffered sample diluent IVD

IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent - 00630414954196

PSA Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386994
In Commercial Distribution

  • 00630414954196 ()
LPSZ

  • Buffered sample diluent IVD

IMMULITE®/IMMULITE®1000 Systems AF AFP Sample Diluent - 00630414953519

AF AFP Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387015
In Commercial Distribution

  • 00630414953519 ()
LAPZ

  • Buffered sample diluent IVD
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