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

  • 10628429001322 ()
PL.1031

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
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
Mixing Sticks
PRO-LAB, INCORPORATED
PL.091P
In Commercial Distribution

  • 10628429000356 ()
PL.091P

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Victory ™ - 00816349012419
BRIVANT LIMITED
Victory 14 (195 cm, 30g)
In Commercial Distribution

  • 00816349012419 ()
H74939471195300

  • Mycobacterium tuberculosis immunoglobulin A (IgA) antibody IVD, reagent
QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control
Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control
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
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
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
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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