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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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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

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

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

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

Multifire Premium - 10884521080706

Pistol Grip Skin Stapler Reload
Covidien LP
059038
Not in Commercial Distribution

  • 20884521080703 ()
  • 10884521080706 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable

Rapid Response - 00722066003343

Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens.
BTNX Inc
FLUab-19C15
In Commercial Distribution

  • 00722066003343 ()
  • 00722066004241 ()
FLUab-19C15

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

Poly stat - 00855574005407

Flu A & B, Immunochromatographic
POLYMEDCO, INC.
FLU22
In Commercial Distribution

  • 00855574005407 ()


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

ClearFit - 00855113008722

ClearFit 1.4cm Cover with Slot
LONGEVITI NEURO SOLUTIONS LLC
171738
In Commercial Distribution

  • 00855113008722 ()


  • Cranial resinous compound

OraSure Quickflu Nasopharyngeal Wash / Aspirate - 00608337000047

No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


  • Influenza A/B virus antigen IVD, reagent
  • Nasopharyngeal aspirate container IVD

CHORUS INFLUENZA B IgG - 08033891327538

No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS INFLUENZA A IgG - 08033891327514

No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Remel - 00848838063701

Xpect Flu A&B Control 20Swab/SET
REMEL, INC.
R246003
In Commercial Distribution

  • 30848838063702 ()
  • 00848838063701 ()


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

Henry Schein - 00304040019771

Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens
HENRY SCHEIN, INC.
1126219
In Commercial Distribution

  • 10304040019778 ()
  • 00304040019771 ()
1126219

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

IMAGEN Influenza Virus A and B - 05032384502981

No Description
OXOID LIMITED
K610511-2
In Commercial Distribution

  • 05032384502981 ()


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

Status Flu A+B card - 10743816001508

Status Flu A+B; 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-25-02
In Commercial Distribution

  • 10743816001508 ()
BSP-510-25-02

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

BioSign Flu A+B card - 10743816001478

BioSign Flu A+B; 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-25-01
In Commercial Distribution

  • 10743816001478 ()
BSP-510-25-01

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

Status Flu A & B - 10743816001447

Status Flu A+B; 5 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-05-00
In Commercial Distribution

  • 10743816001447 ()
BSP-510-05-00

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

Status Flu A+B Validation Kit - 10743816001430

Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Regular Swabs
PRINCETON BIOMEDITECH CORPORATION
BSP-510-22-08
In Commercial Distribution

  • 10743816001430 ()
BSP-510-22-08

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

Status Flu A+B Nasal Wash/Aspirate Kit - 10743816001416

Status Flu A+B Nasopharyngeal Wash/Aspirate Kit; 44 Pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-04
In Commercial Distribution

  • 10743816001416 ()
BSP-510AS-04

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent

Status Flu A+B card - 10743816001218

Status Flu A & B; 4 Test Sample Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-04-00
In Commercial Distribution

  • 10743816001218 ()
BSP-510-04-00

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

BioSign Flu A+B card - 10743816001201

BioSign Flu A+B; 10 Test Kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-510-10-00
In Commercial Distribution

  • 10743816001201 ()
BSP-510-10-00

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

Status Flu A+B card - 10743816001195

Status Flu A+B; 22 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-22-01
In Commercial Distribution

  • 10743816001195 ()
BSP-510-22-01

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

BioSign Flu A+B card - 10743816001188

BioSign Flu A+B; 22 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-22-00
In Commercial Distribution

  • 10743816001188 ()
BSP-510-22-00

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

Poly stat - 00816917022925

Flu A & B, Immunochromatographic, 25 Test Kit
POLYMEDCO, INC.
FLU25
In Commercial Distribution

  • 00816917022925 ()


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

Sofia - 30014613202547

Sofia Flu A+B 25T
QUIDEL CORPORATION
20254
In Commercial Distribution

  • 30014613202547 ()
20254

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

Sofia - 30014613202189

Sofia Flu A+B 25T
QUIDEL CORPORATION
20218
In Commercial Distribution

  • 30014613202189 ()
20218

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

QuickVue - 30014613201830

QkVue Flu A+B 25T, CE
QUIDEL CORPORATION
20183
In Commercial Distribution

  • 30014613201830 ()
20183

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

QuickVue - 30014613003175

QkVue Flu Bulk 25T
QUIDEL CORPORATION
00317
In Commercial Distribution

  • 30014613003175 ()
00317

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

QuickVue - 30014613331469

QkVue Flu A+B 20K-T, Bulk
QUIDEL CORPORATION
20189
In Commercial Distribution

  • 30014613331469 ()
20189

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

OSOM Flu Dipstick 25 Test Kit - 00742860001901

No Description
SEKISUI DIAGNOSTICS, LLC
190
Not in Commercial Distribution

  • 00742860001901 ()
  • 10742860001908 ()
190

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

N/A - 16977977230031

The COVID-19/Flu A&B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19, Influenza A&B Antigen in Nasal swab. It is intended to aid in the rapid differential diagnosis of COVID-19,Influenza A and B
Zhengzhou Shiyi Biotech Co., Ltd.
A003
In Commercial Distribution

  • 26977977230038 ()
  • 16977977230031 ()
  • 06977977230034 ()


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

N/A - 16977977230024

The COVID-19/Flu A&B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19, Influenza A&B Antigen in Nasal swab. It is intended to aid in the rapid differential diagnosis of COVID-19,Influenza A and B
Zhengzhou Shiyi Biotech Co., Ltd.
A002
In Commercial Distribution

  • 26977977230021 ()
  • 16977977230024 ()
  • 06977977230027 ()


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

McKesson - 20612479226795

Influenza A & B Test NASOPHARYNGEAL WASH/ASPIRATE KIT
MCKESSON MEDICAL-SURGICAL INC.
181-36026
In Commercial Distribution

  • 20612479226795 ()


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

OraSure Quick Flu 22-Count Flu A + B Kit - 20608337000065

No Description
Orasure Technologies, Inc.
1001-0320
In Commercial Distribution

  • 20608337000065 ()


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

McKesson - 20612479225118

Influenza A & B Test
MCKESSON MEDICAL-SURGICAL INC.
181-36025
In Commercial Distribution

  • 20612479225118 ()
  • 10612479227351 ()


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

RaPET® ASO - 00657498001233

Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
STANBIO LABORATORY, L.P.
1125-100
In Commercial Distribution

  • 00657498001233 ()
1125-100

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination

RaPET® ASO - 00657498001226

Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
STANBIO LABORATORY, L.P.
1125-050
In Commercial Distribution

  • 00657498001226 ()
1125-050

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination

Cyclosporine C2 Control - 00856743007055

MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood.
MORE DIAGNOSTICS INC
202
In Commercial Distribution

  • 00856743007055 ()
202

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

Trinity Biotech - 05391516748780

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

Trinity Biotech - 05391516747998

Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent

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

cobas® Strep A Quality Control Kit for use on the cobas® Liat® System - 00875197005646

No Description
Roche Molecular Systems, Inc.
07402678190
In Commercial Distribution

  • 00875197005646 ()
07402678190

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

cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System - 00875197005639

No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control

Anti-Fya - 00858400005077

Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510215
In Commercial Distribution

  • 00858400005077 ()


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