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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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Anti-HBe2 (aHBe2) – Atellica IM – QC Kit
Siemens Healthcare Diagnostics Inc.
10733022
In Commercial Distribution

  • 00842768022685 ()
10733022

  • Hepatitis B virus e-antigen total antibody IVD, control
GBS Positive Run Control
EXACT DIAGNOSTICS, LLC
12020069
In Commercial Distribution

  • 03610522384389 ()
12020069

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
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
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™ 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™ 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™ 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
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
QMol GBS Control Set
DIAGNOSTIC HYBRIDS, INC.
M116
In Commercial Distribution

  • 30014613311164 ()
M116

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Panther Fusion® GBS Controls Kit.
Hologic, Inc.
KIT, GBS CONTROLS, FUSION, IVD
In Commercial Distribution

  • 15420045510906 ()
PRD-04485

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