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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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Atellica™ IM aHBs2 MCM - 00630414600512

aHBs2 - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995667
In Commercial Distribution

  • 00630414600512 ()
10995667

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur aHBe2 QC KIT - 00630414167947

Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody IVD, control

Alethia™ Group B Streptococcus External Control Kit - 00840733102110

The Alethia GBS External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479900
In Commercial Distribution

  • 00840733102110 ()
479900

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

illumigene Group B Streptococcus External Control Kit - 00840733101311

The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279900
Not in Commercial Distribution

  • 00840733101311 ()
279900

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357044197

QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel
MICROBIOLOGICS INC.
8258
In Commercial Distribution

  • 70845357044197 ()
8258

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357044180

QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Control Panel
MICROBIOLOGICS INC.
8242
In Commercial Distribution

  • 70845357044180 ()
8242

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357042735

QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8232
In Commercial Distribution

  • 70845357042735 ()
8232

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041219

Assayed GBS LB Control Panel
MICROBIOLOGICS INC.
8194 Cepheid Xpert® GBS LB Control Panel
Not in Commercial Distribution

  • 70845357041219 ()
8194

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Influenza B Negative Control - B110IBN21100

No Description
Bion Enterprises, Ltd.
IBN-2110
In Commercial Distribution

  • B110IBN21100 ()
IBN-2110

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control

Influenza B IgG Control - B110IBG21200

No Description
Bion Enterprises, Ltd.
IBG-2120
In Commercial Distribution

  • B110IBG21200 ()
IBG-2120

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control
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