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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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Elecsys PreciControl Anti-HBc IgM - 04015630911622

No Description
Roche Diagnostics GmbH
11876333160
Not in Commercial Distribution

  • 04015630911622 ()
11876333160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

Elecsys Anti-HBc IgM Immunoassay - 04015630911615

No Description
Roche Diagnostics GmbH
11820567160
Not in Commercial Distribution

  • 04015630911615 ()
11820567160

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

Elecsys HBsAg Confirmatory Test - 04015630911110

No Description
Roche Diagnostics GmbH
11820648122
Not in Commercial Distribution

  • 04015630911110 ()
11820648122

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Immunoassay - 04015630911073

No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Elecsys PreciControl HBsAg - 04015630911059

No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control

Elecsys PreciControl Anti-HBs - 04015630910908

No Description
Roche Diagnostics GmbH
11876317160
Not in Commercial Distribution

  • 04015630910908 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control

Zilver 518 - 10827002493336

Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49333
Not in Commercial Distribution

  • 10827002493336 ()
ZIVX5-18-125-10-80

  • Peripheral artery stent, bare-metal

Zilver 518 - 10827002493329

Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49332
Not in Commercial Distribution

  • 10827002493329 ()
ZIVX5-18-125-10-60

  • Peripheral artery stent, bare-metal

Zilver 518 - 10827002493312

Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49331
Not in Commercial Distribution

  • 10827002493312 ()
ZIVX5-18-125-10-40

  • Peripheral artery stent, bare-metal

Zilver 518 - 10827002493305

Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49330
Not in Commercial Distribution

  • 10827002493305 ()
ZIVX5-18-125-10-30

  • Peripheral artery stent, bare-metal
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