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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Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control
Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control
HBc Total (HBcT) Assay Kit 200T
Siemens Healthcare Diagnostics Inc.
10309508
In Commercial Distribution

  • 00630414498096 ()
7566733

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HBc Total (HBcT) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10309509
In Commercial Distribution

  • 00630414498089 ()
7569996

  • Hepatitis B virus core total antibody IVD, control
Anti-HBc IgM CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
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
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
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
AF AFP Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381162
In Commercial Distribution

  • 00630414963594 ()
LKAP1

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
AF AFP Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381184
In Commercial Distribution

  • 00630414961040 ()
L2KAP6

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