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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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iotaSOFT Insertion System - 00850002960044

iotaSOFT Rolling Stand
Iotamotion, Inc.
IM-04
In Commercial Distribution

  • 00850002960044 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960037

iotaSOFT Footpedal
Iotamotion, Inc.
IM-03
In Commercial Distribution

  • 00850002960037 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960020

iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960006

iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software

Fluoro-CheckTM Influenza A+B - 00895160002526

An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

ImmunoCard STAT! FLU A&B - 00840733101656

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.
MERIDIAN BIOSCIENCE, INC.
782030
In Commercial Distribution

  • 00840733101656 ()
782030

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit - 00840733101649

Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples.
MERIDIAN BIOSCIENCE, INC.
781130
In Commercial Distribution

  • 00840733101649 ()
781130

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

BinaxNOW Influenza A & B Card 2 - 10811877010972

A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens.
Alere Scarborough, Inc.
575-000
In Commercial Distribution

  • 10811877010972 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Alere Influenza A & B Test - 10811877010873

A rapid test for the qualitative detection of Influenza A & B Antigens in nasal swab specimens.
Alere Scarborough, Inc.
412-000
Not in Commercial Distribution

  • 10811877010873 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Alere BinaxNOW Influenza A & B Card 2 - 10811877010156

A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens
Alere Scarborough, Inc.
575-000
Not in Commercial Distribution

  • 10811877010156 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

BD Veritor™ System CLIA-Waived Combo Pack - 00382902560715

BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
BECTON, DICKINSON AND COMPANY
256071
Not in Commercial Distribution

  • 00382902560715 ()
256071

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit - 00382902560456

Kit Flu A+B 30 Test Physician Veritor
BECTON, DICKINSON AND COMPANY
256045
In Commercial Distribution

  • 00382902560456 ()
256045

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit - 00382902560418

Kit Flu A+B 30 Test Hospital Veritor
BECTON, DICKINSON AND COMPANY
256041
In Commercial Distribution

  • 00382902560418 ()
256041

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

OSOM ULTRA PLUS FLU A&B Test - 00742860100390

No Description
SEKISUI DIAGNOSTICS, LLC
1032
In Commercial Distribution

  • 10742860100397 ()
  • 00742860100390 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Acucy Flu Test Kit - 00742860100376

Acucy Influenza A&B Test Kit
SEKISUI DIAGNOSTICS, LLC
1010
In Commercial Distribution

  • 00742860100376 ()
  • 10742860100373 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Acucy Calibration Device - 00742860100345

No Description
SEKISUI DIAGNOSTICS, LLC
1031
Not in Commercial Distribution

  • 00742860100345 ()


  • Optical laboratory instrument performance standard calibrator/control IVD, reusable

Acucy System - 00742860100338

No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD

OSOM Ultra Flu Aspirate 25T Kit - 00742860100239

OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
1007
In Commercial Distribution

  • 00742860100239 ()
  • 10742860100236 ()
1007

  • Nasopharyngeal aspirate container IVD

OSOM Ultra Flu A&B 25T Kit - 00742860100222

OSOM Ultra Flu A&B 25T Kit
SEKISUI DIAGNOSTICS, LLC
1006
In Commercial Distribution

  • 00742860100222 ()
  • 10742860100229 ()
1006

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Silaris Dock - B54010260

The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Appose ULC - 10884521104372

Slim Body Skin Stapler
Covidien LP
8886803712
In Commercial Distribution

  • 20884521104379 ()
  • 10884521104372 ()
  • 30884521104376 ()

  • Wide,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable

Appose ULC - 10884521104365

Slim Body Skin Stapler
Covidien LP
8886803512
In Commercial Distribution

  • 30884521104369 ()
  • 10884521104365 ()
  • 20884521104362 ()

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable

Powered LDS - 10884521057470

Powered Ligating and Dividing Stapler
Covidien LP
092001
Not in Commercial Distribution

  • 20884521057477 ()
  • 10884521057470 ()

  • Wide,N/A,N/A;
092001

  • Ligation clip, metallic

DFS - 10884521080744

Fascia Stapler
Covidien LP
070614
Not in Commercial Distribution

  • 20884521080741 ()
  • 10884521080744 ()

  • Width,N/A,N/A;
070614

  • Open-surgery manual linear stapler, single-use

SM - 10884521080737

Skin Stapler Reload
Covidien LP
050284
Not in Commercial Distribution

  • 20884521080734 ()
  • 10884521080737 ()

  • Width,N/A,N/A;


  • Surgical staple loading unit, non-cutting

SM - 10884521080720

Skin Stapler Reload
Covidien LP
050258
Not in Commercial Distribution

  • 20884521080727 ()
  • 10884521080720 ()

  • Regular,N/A,N/A;


  • Surgical staple loading unit, non-cutting

Multifire Premium - 10884521080690

Pistol Grip Skin Stapler
Covidien LP
059037
In Commercial Distribution

  • 20884521080697 ()
  • 10884521080690 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable

Multifire Premium - 10884521080683

Pistol Grip Skin Stapler Reload
Covidien LP
059036
In Commercial Distribution

  • 20884521080680 ()
  • 10884521080683 ()

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable

Multifire Premium - 10884521080676

Pistol Grip Skin Stapler
Covidien LP
059035
In Commercial Distribution

  • 20884521080673 ()
  • 10884521080676 ()

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable

Signet - 10884521080669

Skin Stapler
Covidien LP
054006
In Commercial Distribution

  • 20884521080666 ()
  • 10884521080669 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
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