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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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No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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
The NATtrol™ Influenza/RSV Negative 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/RSV Negative 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/RSV Negative Control
In Commercial Distribution

  • 01220000260078 ()
NATCXVA9-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3923
Not in Commercial Distribution

  • 00840487100219 ()
3923

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

  • 00816349012419 ()
H74939471195300

  • Mycobacterium tuberculosis immunoglobulin A (IgA) antibody IVD, reagent
ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
Diagnostic Automation, Inc.
DACD330-50
In Commercial Distribution

  • 00894175000619 ()

  • 50 Tests/Kit
330-50

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination
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
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
The Anti-Lea reagent (Anti-LE1) is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904557
In Commercial Distribution

  • 10758750013104 ()


  • Anti-Le^a red blood cell grouping IVD, antibody
The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904548
In Commercial Distribution

  • 10758750013029 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904546
In Commercial Distribution

  • 10758750013005 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Anti-Jka (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721380
In Commercial Distribution

  • 10758750004140 ()
721380

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