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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No Description
Bird & Cronin, LLC
08143237
In Commercial Distribution

  • 00610570012176 ()


  • Lumbar spine orthosis
No Description
Bird & Cronin, LLC
08142632
In Commercial Distribution

  • 00610570010264 ()


  • Lumbar spine orthosis
No Description
ALIMED, INC.
65961
In Commercial Distribution

  • 00733657217421 ()
2970005851

  • Abdominal binder, reusable
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008442 ()
C206

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 fusion gene.
Mmqci
v.00
In Commercial Distribution

  • 00852720008336 ()
C230

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008114 ()
M441

  • Multiple-genus respiratory virus nucleic acid IVD, control
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP EZ assay on the FilmArray systems.
Mmqci
v.00
Not in Commercial Distribution

  • 00852720008046 ()
M265

  • Multiple-genus respiratory virus nucleic acid IVD, control
Four Drug PreScreen Plus (CLIA Waived) Dip Card Combo: COC|MET|THC|OPI
MERGERS MARKETING, INC.
PS-DOA-144
In Commercial Distribution

  • 10851000007295 ()
  • 00851000007298 ()
  • 00851000007281 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria
BIOMERIEUX , INC.
VITEK® REVEAL™ SENSOR PANEL
In Commercial Distribution

  • 03573026638900 ()
  • 00860007326929 ()


  • Antibacterial susceptibility testing disc IVD
inSight 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
IS-12P-CW
In Commercial Distribution

  • 20817038022249 ()
  • 10817038022242 ()
  • 00817038022245 ()
IS-12P-CW

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.
Luminex Molecular Diagnostics, Inc
I055C0465
In Commercial Distribution

  • 00840487101872 ()
I055C0465

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis.
Luminex Molecular Diagnostics, Inc
I032C0316
In Commercial Distribution

  • 00840487100493 ()
I032C0316

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections.
Luminex Molecular Diagnostics, Inc
I019C0111
Not in Commercial Distribution

  • 00840487100462 ()
I019C0111

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centromere pattern 5. 1x 0.5 ANA Scl-70 pattern
INOVA DIAGNOSTICS, INC.
708180
In Commercial Distribution

  • 08426950594857 ()


  • Multiple antinuclear antibody (ANA) screening IVD, control
Strip description for the invitro quantitative determination of ALP, AST, and ALT activity, and total bilirubin and total protein concentration in human plasma from whole blood samples
ARKRAY USA, INC.
77127
Not in Commercial Distribution

  • 00015482771270 ()
  • 50015482771275 ()


  • Magnesium (Mg2+) IVD, kit, spectrophotometry
Strip description for the invitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine concentration in human plasma from whole blood samples
ARKRAY USA, INC.
77126
Not in Commercial Distribution

  • 00015482771263 ()
  • 50015482771268 ()


  • Magnesium (Mg2+) IVD, kit, spectrophotometry
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423738
Not in Commercial Distribution

  • 00815381020482 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0142
In Commercial Distribution

  • 00815381020321 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0143
In Commercial Distribution

  • 00815381020314 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0135
In Commercial Distribution

  • 00815381020208 ()


  • Multiple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 kits.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0138
In Commercial Distribution

  • 00815381020192 ()


  • Multiple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0130
Not in Commercial Distribution

  • 00815381020161 ()
RFIT-ASY-0130

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0129
Not in Commercial Distribution

  • 00815381020154 ()
RFIT-ASY-0129

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0119
In Commercial Distribution

  • 00815381020130 ()
RFIT-ASY-0119

  • Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0118
In Commercial Distribution

  • 00815381020123 ()
RFIT-ASY-0118

  • Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
GREAT BASIN SCIENTIFIC, INC.
GBSIDR-10
In Commercial Distribution

  • B178GBSIDR102 ()
  • B178GBSIDR100 ()
GBSIDR-10

  • MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
  • MRSE nucleic acid detection IVD, kit, nucleic acid technique (NAT)
  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
  • MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
COC300/THC50
ALERE SAN DIEGO, INC.
DOA-124-031-a
In Commercial Distribution

  • 10810124273870 ()
  • 00810124273873 ()
4566631326

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC300/AMP1000/THC50
ALERE SAN DIEGO, INC.
DOA-134-011-a
In Commercial Distribution

  • 10810124273863 ()
  • 00810124273866 ()
4566621326

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC300/AMP1000/mAMP1000/THC50/OPI2000
ALERE SAN DIEGO, INC.
DOA-154-201-a
In Commercial Distribution

  • 10810124273856 ()
  • 00810124273859 ()
4566611326

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC300/AMP1000/THC50/BAR300/BZO300
ALERE SAN DIEGO, INC.
DOA-154-061-a
In Commercial Distribution

  • 10810124273849 ()
  • 00810124273842 ()
4566601326

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300
ALERE SAN DIEGO, INC.
DOA-164-141-a
In Commercial Distribution

  • 10810124273832 ()
  • 00810124273835 ()
4566591326

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Optional Bariatric Pivoting Calf Panel Assembly for use with the LNX Power Center Mount Legrest (upper assy) or the Compact Power Down LNX CM Legrest. Includes mounting hardware. Padded Calf Panel sold separately. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0101-LNXPCP
In Commercial Distribution

  • 07540147002886 ()
LNXPCP

  • Wheelchair footrest/legrest
QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Not in Commercial Distribution

62006

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL
Ls Enterprises, Inc.
2184BC
In Commercial Distribution

  • D0692184BC0 ()


  • Dental delivery system
The E-Series Spindle Hybrid Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171155 ()
LES000019

  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171056 ()
LES000007

  • Medical monitor/light mount
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000392 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000361 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 10855944007274 ()
  • 00855944007277 ()
  • 30855944007278 ()
ACDOA-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (5 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007260 ()
  • 30855944007261 ()
  • 10855944007267 ()
ACDOA-754-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (100 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007550 ()
  • 30855944007551 ()
ACDOA-754-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (50 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007543 ()
  • 30855944007544 ()
ACDOA-754-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (10 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution

  • 00855944007536 ()
  • 30855944007537 ()
ACDOA-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 8 Panel Cup Test: AMP1000/COC300/mAMP1000/MDMA500/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-684
In Commercial Distribution

  • 00856464008379 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Five Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
CSC-654
In Commercial Distribution

  • 10850557007871 ()
  • 00850557007874 ()
  • 00850557007867 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
CSC-254
In Commercial Distribution

  • 10850557007833 ()
  • 00850557007836 ()
  • 00850557007829 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PSC-DOA-654
In Commercial Distribution

  • 00850557007546 ()
  • 10850557007550 ()
  • 00850557007553 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PSC-DOA-254
In Commercial Distribution

  • 00850557007423 ()
  • 00850557007430 ()
  • 10850557007437 ()


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