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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GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,L
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OL
In Commercial Distribution

  • 20888277418162 ()
  • 10888277418165 ()
MDTAUSGXP4OL

  • Surgical gown, reusable
Drugs of Abuse Test 10-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-8105A3
In Commercial Distribution

  • 40612479228823 ()
  • 20612479228812 ()
  • 10612479231013 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 14-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-1145A3
In Commercial Distribution

  • 40612479228809 ()
  • 20612479228799 ()
  • 10612479231006 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-6125A3
In Commercial Distribution

  • 40612479228786 ()
  • 20612479228775 ()
  • 10612479230993 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-5125A3
In Commercial Distribution

  • 40612479228762 ()
  • 20612479228751 ()
  • 10612479230986 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Cotinine (COT) Rapid Test Panel box of 40
Hangzhou AllTest Biotech Co., Ltd.
DCT-114
In Commercial Distribution

  • 06970277512527 ()
  • 06970277512510 ()
DCT-114

  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
PANEL DRAPE W/ADHESIVE 30 X 24, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426068969 ()
  • 00748426068968 ()
  • 50748426068963 ()


  • Instrument/equipment drape, single-use, sterile
PANEL DRAPE W/ADHESIVE 30 X 24, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426025269 ()
  • 00748426025268 ()
  • 50748426025263 ()


  • Instrument/equipment drape, single-use, sterile
GENESIS II FEMORAL TRIALS L TRAY PANEL SIZE1-6
Smith & Nephew, Inc.
71442197
In Commercial Distribution

  • 00885556625354 ()
71442197

  • Instrument tray, reusable
The Single Flat Panel Monitor, Single Flat Panel Monitor Spindle G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166748 ()
LGH00043

  • Medical monitor/light mount
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-009-020
Not in Commercial Distribution

  • 00857573006232 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-006-020
Not in Commercial Distribution

  • 00857573006133 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution

  • 00857573006294 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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)
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)
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)
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)
No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
07341890190
In Commercial Distribution

  • 00875197005608 ()
07341890190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
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
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)
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)
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)
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
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)
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
No Description
Roche Molecular Systems, Inc.
08085463001
In Commercial Distribution

  • 07613336129685 ()
08085463001

  • Laboratory instrument/analyser application software IVD
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)
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