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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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JBAIDS - 00851458005068

JBAIDS IVD Influenza A & B Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0137
Not in Commercial Distribution

  • 00851458005068 ()
JRPD-ASY-0137

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Genedrive(R)96 SARS-CoV2-kit - 05060654860127

Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860127 ()
  • 05060654860080 ()
ID-CoV2-01-FPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Genedrive(R) 96 SARS CoV2 kit - 05060654860103

Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument.
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860103 ()
  • 05060654860110 ()
ID-CoV2-01-BPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Genedrive(R)96 SARS-CoV2-kit - 05060654860059

Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Roche LightCycler 11 instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860059 ()
  • 05060654860134 ()
ID-CoV2-01-LPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

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

cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System - 00875197005608

No Description
Roche Molecular Systems, Inc.
07341890190
In Commercial Distribution

  • 00875197005608 ()
07341890190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ARGENE® ADENOVIRUS R-gene KIT US - 03573026403997

ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings.
BIOMERIEUX SA
69-010B-US
Not in Commercial Distribution

  • 03573026403997 ()


  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Accula Flu A / B Control Kit - B540FAB1100CWC0

The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

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

Accula Flu A / B Test - B540FAB1100CW0

The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
FAB1100CW
In Commercial Distribution

  • B540FAB1100CW0 ()
FAB1100CW

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Silaris RSV Supplemental Pack - B54010400

The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA. The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical and epidemiological risk factors.
MESA BIOTECH, INC.
1040
In Commercial Distribution

  • B54010400 ()
1040

  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Sialris Influenza A&B Supplemental Pack - B54010350

The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
1035
In Commercial Distribution

  • B54010350 ()
1035

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Silaris RSV Control Kit - B54010290

The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
MESA BIOTECH, INC.
1029
In Commercial Distribution

  • B54010290 ()
1029

  • Respiratory syncytial virus (RSV) nucleic acid IVD, control

Silaris Influenza A&B Test - B54010270

The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
1027
In Commercial Distribution

  • B54010270 ()
1027

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Silaris Influenza A&B Control Kit - B54010240

The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

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

cobas® Liat® Influenza A/B Script - 07613336129685

No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD

Solana - 30014613336143

Solana RSV/hMPB Assay
DIAGNOSTIC HYBRIDS, INC.
M306
In Commercial Distribution

  • 30014613336143 ()
M306

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Solana - 30014613336068

Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution

  • 30014613336068 ()
M300

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Lyra - 30014613311133

Lyra Adenovirus Assay
QUIDEL CORPORATION
Adenovirus Assay
In Commercial Distribution

  • 30014613311133 ()
M113

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert Xpress Flu - 07332940006044

Xpert Xpress Flu kit; 10 test kit
CEPHEID
XPRSFLU-10
In Commercial Distribution

  • 07332940006044 ()
XPRSFLU-10

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert Xpress Flu/RSV - 07332940005696

Xpert Xpress Flu/RSV kit; 10 test kit
CEPHEID
XPRSFLU/RSV-10
In Commercial Distribution

  • 07332940005696 ()
XPRSFLU/RSV-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert Flu+RSV Xpress - 07332940005177

Xpert Flu+RSV Xpress kit; 10 test kit
CEPHEID
GXFLU+RSV-XP-10
Not in Commercial Distribution

  • 07332940005177 ()
GXFLU+RSV-XP-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert FLU/RSV XC - 07332940000783

Xpert FLU/RSV XC kit; 10 test kit
CEPHEID
GXFLU/RSV-10
In Commercial Distribution

  • 07332940000783 ()
GXFLU/RSV-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Flu A/B & RSV Positive Control Pack - 20816101025552

No Description
DIASORIN MOLECULAR LLC
MOL2660
In Commercial Distribution

  • 20816101025552 ()
MOL2660

  • Multiple-genus respiratory virus nucleic acid IVD, control

Simplexa™ Flu A/B & RSV Direct - 20816101025545

No Description
DIASORIN MOLECULAR LLC
MOL2650
Not in Commercial Distribution

  • 20816101025545 ()
MOL2650

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Flu A/B & RSV - 20816101025538

No Description
DIASORIN MOLECULAR LLC
MOL2600
In Commercial Distribution

  • 20816101025538 ()
MOL2600

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ HSV 1 & 2 Positive Control Pack - 20816101025514

No Description
DIASORIN MOLECULAR LLC
MOL2160
In Commercial Distribution

  • 20816101025514 ()
MOL2160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Simplexa™ HSV 1 & 2 Direct - 20816101025507

No Description
DIASORIN MOLECULAR LLC
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Panther Fusion® - 15420045509238

Panther Fusion® Specimen Lysis Tubes.
Hologic, Inc.
SPECIMEN LYSIS TUBES, IVD
In Commercial Distribution

  • 15420045509238 ()
PRD-04339

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

PRODESSE - 15420045506381

No Description
Hologic, Inc.
PROADENO+ KIT, 100 REACTIONS
Not in Commercial Distribution

  • 15420045506381 ()
303675

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

PRODESSE - 15420045506343

No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 1,500 REACTIONS
Not in Commercial Distribution

  • 15420045506343 ()
303123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

PRODESSE - 15420045506336

No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 2,000 REACTIONS
Not in Commercial Distribution

  • 15420045506336 ()
303121

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

PRODESSE - 15420045506329

No Description
Hologic, Inc.
PRODESSE PROFLU+ ASSAY
Not in Commercial Distribution

  • 15420045506329 ()
303111

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Idylla™ Respiratory (IFV-RSV) Panel - 15415219000635

No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

HarmonyAIR - 00724995166724

The Single Flat Panel Monitor, Light Head Single Flat Panel Monitor-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166724 ()
10088703

  • Medical monitor/light mount

DR-ID 1300MP - 04547410322934

A device supplying power to the flat panel sensor and connecting between the flat panel sensor and image processing unit.
FUJIFILM CORPORATION
DR-ID 1300 MP E
In Commercial Distribution

  • 04547410322934 ()


  • Stationary basic diagnostic x-ray system, digital

MicroScan - 15099590703271

CD, Labpro V4.42 Panel Update-07 LabPro V4.42 Panel Update-07 Kit (US, OUS) LabPro V4.42 System Kit wPanel Update-07 (US,OUS)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590703110 ()
  • 15099590703271 ()
  • 15099590703127 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

Enteric Pathogens (EP) Stool Sample Preparation Kit - 00857573006065

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
30-002-023
Not in Commercial Distribution

  • 00857573006065 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Amplification Tray - 00857573006089

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution

  • 00857573006089 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Extraction Tray - 00857573006058

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-009-023
Not in Commercial Distribution

  • 00857573006058 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Nucleic Acid Test Cartridge - 00857573006041

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-006-023
Not in Commercial Distribution

  • 00857573006041 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Stool Sample Preparation Kit - 00840487101568

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
30-002-023
In Commercial Distribution

30-002-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Extraction Tray - 00840487101551

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-009-023
In Commercial Distribution

20-009-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Amplification Tray - 00840487101544

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-011-023
In Commercial Distribution

20-011-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Nucleic Acid Test Cartridge - 00840487101520

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-006-023
In Commercial Distribution

20-006-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

SPOTFIRE RSP Negative Control - 00852720008107

NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini
Mmqci
v.00
In Commercial Distribution

  • 00852720008107 ()
M42738

  • Multiple-genus respiratory virus nucleic acid IVD, control

Healgen (Private Label) - 242 - 00856464008348

Healgen (DrugConfirm) - 4 panel Cup AMP1000/COC300/MET1000/OPI2000
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-242
In Commercial Distribution

  • 00856464008348 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent

eSensor® XT-8 - 00857167005122

eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005122 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

eSensor® XT-8 - 00857167005092

eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005092 ()
KT021620

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

At Home Single Panel COC + Timer - 00674033090736

Single Panel Cocaine urine drug test device with Timer
PHAMATECH, INCORPORATED
9073T
In Commercial Distribution

  • 00674033090736 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

MD DugScreen - 00850969007929

CLIA Waived Morphine 300 ng/ml Test Panel (MOP)
Medical Disposables Corp
M-DMO-114
In Commercial Distribution

  • 00850969007929 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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