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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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Exact Diagnostics - 03610522384389

GBS Positive Run Control
EXACT DIAGNOSTICS, LLC
12020069
In Commercial Distribution

  • 03610522384389 ()
12020069

  • Beta-haemolytic Group B Streptococcus nucleic acid 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

Quidel Molecular - 30014613311164

QMol GBS Control Set
DIAGNOSTIC HYBRIDS, INC.
M116
In Commercial Distribution

  • 30014613311164 ()
M116

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

Panther Fusion® - 15420045510906

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

Fungal Serology - 10634853000022

Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control
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