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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QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control
No Description
Microgenics Corporation
100012
In Commercial Distribution

  • 00884883001299 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual tube method.
DIAGAST
210541
In Commercial Distribution

  • 23661562105414 ()
210541

  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
DIAGAST
210534
In Commercial Distribution

  • 23661562105346 ()
210534

  • Anti-Jk^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method.
DIAGAST
210531
In Commercial Distribution

  • 23661562105315 ()
210531

  • Anti-Fy^a red blood cell grouping IVD, antibody
No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control
Group A Strep (GAS) Primers ASR.
Hologic, Inc.
DNA GAS PRIMERS (ASR)
In Commercial Distribution

  • 15420045511590 ()
PRD-05050

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Group A Strep (GAS) Probe ASR.
Hologic, Inc.
DNA GAS PROBE (ASR)
In Commercial Distribution

  • 15420045511576 ()
PRD-05051

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Hologic GAS Plasmid Control.
Hologic, Inc.
LBLD, GAS PLASMID (UNASSAYED CONTROL)
In Commercial Distribution

  • 15420045511552 ()
PRD-05052

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control
ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
ABBOTT LABORATORIES
1L75-55
In Commercial Distribution

  • 00380740001322 ()
01L7555

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
ARCHITECT Cyclosporine Calibrators
ABBOTT LABORATORIES
1L75-01
In Commercial Distribution

  • 00380740001308 ()
01L7501

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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
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
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)
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
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
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
No Description
OXOID LIMITED
K610511-2
In Commercial Distribution

  • 05032384502981 ()


  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


  • Influenza A/B virus antigen IVD, reagent
  • Nasopharyngeal aspirate container IVD
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
Sofia Flu A+B 25T
QUIDEL CORPORATION
20254
In Commercial Distribution

  • 30014613202547 ()
20254

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

  • 30014613003175 ()
00317

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