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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Slim Body Skin Stapler
Covidien LP
8886803712
In Commercial Distribution

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

  • Wide,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
Slim Body Skin Stapler
Covidien LP
8886803512
In Commercial Distribution

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

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
Skin Stapler Reload
Covidien LP
050258
Not in Commercial Distribution

  • 20884521080727 ()
  • 10884521080720 ()

  • Regular,N/A,N/A;


  • Surgical staple loading unit, non-cutting
Pistol Grip Skin Stapler
Covidien LP
059037
In Commercial Distribution

  • 20884521080697 ()
  • 10884521080690 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
Pistol Grip Skin Stapler
Covidien LP
059035
In Commercial Distribution

  • 20884521080673 ()
  • 10884521080676 ()

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
Powered Ligating and Dividing Stapler
Covidien LP
092001
Not in Commercial Distribution

  • 20884521057477 ()
  • 10884521057470 ()

  • Wide,N/A,N/A;
092001

  • Ligation clip, metallic
Fascia Stapler
Covidien LP
070614
Not in Commercial Distribution

  • 20884521080741 ()
  • 10884521080744 ()

  • Width,N/A,N/A;
070614

  • Open-surgery manual linear stapler, single-use
Skin Stapler Reload
Covidien LP
050284
Not in Commercial Distribution

  • 20884521080734 ()
  • 10884521080737 ()

  • Width,N/A,N/A;


  • Surgical staple loading unit, non-cutting
Pistol Grip Skin Stapler Reload
Covidien LP
059038
In Commercial Distribution

  • 20884521080703 ()
  • 10884521080706 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
Pistol Grip Skin Stapler Reload
Covidien LP
059036
In Commercial Distribution

  • 20884521080680 ()
  • 10884521080683 ()

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
Skin Stapler
Covidien LP
054006
In Commercial Distribution

  • 20884521080666 ()
  • 10884521080669 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
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
Flu A & B, Immunochromatographic
POLYMEDCO, INC.
FLU22
In Commercial Distribution

  • 00855574005407 ()


  • Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical
ClearFit 1.4cm Cover with Slot
LONGEVITI NEURO SOLUTIONS LLC
171738
In Commercial Distribution

  • 00855113008722 ()


  • Cranial resinous compound
No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


  • Influenza A/B virus antigen IVD, reagent
  • Nasopharyngeal aspirate container IVD
No Description
OXOID LIMITED
K610511-2
In Commercial Distribution

  • 05032384502981 ()


  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
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
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
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; 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; 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; 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 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; 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; 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; 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; 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
No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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 Flu A+B 25T
QUIDEL CORPORATION
20254
In Commercial Distribution

  • 30014613202547 ()
20254

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Sofia Flu A+B 25T
QUIDEL CORPORATION
20218
In Commercial Distribution

  • 30014613202189 ()
20218

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
QkVue Flu A+B 25T, CE
QUIDEL CORPORATION
20183
In Commercial Distribution

  • 30014613201830 ()
20183

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
QkVue Flu Bulk 25T
QUIDEL CORPORATION
00317
In Commercial Distribution

  • 30014613003175 ()
00317

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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
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
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
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
No Description
Orasure Technologies, Inc.
1001-0320
In Commercial Distribution

  • 20608337000065 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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
No Description
SEKISUI DIAGNOSTICS, LLC
190
Not in Commercial Distribution

  • 00742860001901 ()
  • 10742860001908 ()
190

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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
No Description
Roche Molecular Systems, Inc.
07402678190
In Commercial Distribution

  • 00875197005646 ()
07402678190

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
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
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
No Description
FUJIREBIO DIAGNOSTICS, INC.
4008086
In Commercial Distribution

  • 00869164000079 ()

  • 100 tests per kit


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510215
In Commercial Distribution

  • 00858400005077 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510204
In Commercial Distribution

  • 00858400005022 ()


  • Anti-Kp^a red blood cell grouping IVD, antibody
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z164U
In Commercial Distribution

  • 05060242472497 ()
  • 05060242472480 ()
  • 05060242472503 ()


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