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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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Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
DIAGAST
210534
In Commercial Distribution

  • 23661562105346 ()
210534

  • Anti-Jk^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method.
DIAGAST
210531
In Commercial Distribution

  • 23661562105315 ()
210531

  • Anti-Fy^a red blood cell grouping IVD, antibody
Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control
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
No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma.
Mercodia AB
10-1106-01
In Commercial Distribution

  • 07350108630016 ()
10-1106-01

  • Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)
Blood Grouping Reagent Anti-Lea (LE1); Seraclone® Murine Monoclonal (LEA2); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808403100
In Commercial Distribution

  • 07611969951970 ()
808403100

  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-Fya (FY1); Seraclone® Human Monoclonal (DG-FYA-02); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808188100
In Commercial Distribution

  • 07611969951833 ()
808188100

  • Anti-Fy^a red blood cell grouping IVD, antibody
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
The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Influenza A/B Positive Control
In Commercial Distribution

  • 01220000260085 ()
NATFLUAB-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control
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