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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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Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206631
In Commercial Distribution

  • 05391516748780 ()
1206631

  • Clostridium difficile toxin A/B antigen IVD, control
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
Clostridium difficile Toxin Control, 1.0 mL
MARDX DIAGNOSTICS, INC.
B1029-70A
In Commercial Distribution

  • 05391516747936 ()
B1029-70A

  • Clostridium difficile toxin A/B antigen IVD, control
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
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
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 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
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