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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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Prolex Group A Streptococcal Xtra Latex Reagent - 10628429001322

Group A Latex Reagent
PRO-LAB, INCORPORATED
PL.1031
In Commercial Distribution

  • 10628429001322 ()
PL.1031

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Prolex Latex Agglutination Test Cards - 10628429000370

A range of accessory products to complement the Prolex™ Staph Latex group of products.
PRO-LAB, INCORPORATED
PL.092-48
In Commercial Distribution

  • 10628429000370 ()
PL.092-48

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Prolex Mixing Sticks - 10628429000356

Mixing Sticks
PRO-LAB, INCORPORATED
PL.091P
In Commercial Distribution

  • 10628429000356 ()
PL.091P

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Victory ™ - 00816349012419

Victory ™ - 00816349012419
BRIVANT LIMITED
Victory 14 (195 cm, 30g)
In Commercial Distribution

  • 00816349012419 ()
H74939471195300

  • Mycobacterium tuberculosis immunoglobulin A (IgA) antibody IVD, reagent

Quidel Molecular - 30014613311065

QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control

Solana - 30014613336990

Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control

Monobind AccuBind PRL ELISA Kit - 96 Wells - 00816870021027

No Description
MONOBIND, INC.
725-300
In Commercial Distribution

  • 00816870021027 ()

  • Width: 7.75 Inch
725-300A

  • Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, radioimmunoassay

Panther Fusion® - 15420045511590

Group A Strep (GAS) Primers ASR.
Hologic, Inc.
DNA GAS PRIMERS (ASR)
In Commercial Distribution

  • 15420045511590 ()
PRD-05050

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Panther Fusion® - 15420045511576

Group A Strep (GAS) Probe ASR.
Hologic, Inc.
DNA GAS PROBE (ASR)
In Commercial Distribution

  • 15420045511576 ()
PRD-05051

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Panther Fusion® - 15420045511552

Hologic GAS Plasmid Control.
Hologic, Inc.
LBLD, GAS PLASMID (UNASSAYED CONTROL)
In Commercial Distribution

  • 15420045511552 ()
PRD-05052

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