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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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Seraclone® Anti-Jka (JK1) - 07611969951758

Blood Grouping Reagent Anti-Jka (JK1); Seraclone® Human Monoclonal (MS15); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808179100
In Commercial Distribution

  • 07611969951758 ()
808179100

  • Anti-Jk^a red blood cell grouping IVD, antibody

QC Sets and Panels: Helix Elite™ - 70845357041493

QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
MICROBIOLOGICS INC.
8219
In Commercial Distribution

  • 70845357041493 ()
8219

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

Victory ™ - 00816349012419

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

  • 00816349012419 ()
H74939471195300

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

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

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

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

Alere™ i Influenza A & B Control Swab Kit - 10811877010811

Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control

ID NOW Strep A 2 Control Swab Kit - 10811877010583

Control Swabs intended for use only with the ID NOW Strep A 2 product.
Alere Scarborough, Inc.
734-080
In Commercial Distribution

  • 10811877010583 ()


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

ID NOW Influenza A & B Control Swab Kit - 10811877010439

Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control
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