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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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Trinity Biotech - 05391516747936

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

illumigene Group A Streptococcus External Control Kit - 00840733101328

The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279910
Not in Commercial Distribution

  • 00840733101328 ()
279910

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

MultiCode® Group A Strep Primers - 00840487100219

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

InstaTest™ - 00894175000619

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

Alere™ i Strep A Control Swab Kit - 10811877010866

Control Swabs intended for use only with the Alere i Strep A product.
Alere Scarborough, Inc.
733-080
Not in Commercial Distribution

  • 10811877010866 ()


  • Beta-haemolytic Group A Streptococcus 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

Alere i Strep A 2 Control Swab Kit - 10811877010200

Control Swabs intended for use only with the Alere i Strep A 2 product.
Alere Scarborough, Inc.
734-080
Not in Commercial Distribution

  • 10811877010200 ()


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

Cyclosporine Calibrator 0 ng/mL - 04015630915644

No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Cyclosporine Calibrators - 04015630915637

No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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