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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Thirteen Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
CSC-2135
In Commercial Distribution

  • 10850557007994 ()
  • 00850557007997 ()
  • 00850557007980 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-6125
In Commercial Distribution

  • 00850557007966 ()
  • 00850557007973 ()
  • 10850557007970 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
CSC-8104
In Commercial Distribution

  • 00850557007942 ()
  • 00850557007959 ()
  • 10850557007956 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
CSC-4104
In Commercial Distribution

  • 00850557007928 ()
  • 00850557007935 ()
  • 10850557007932 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel Clear Scan Drug Test Cup Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
CSC-3104
In Commercial Distribution

  • 00850557007904 ()
  • 00850557007911 ()
  • 10850557007918 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | EDDP | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-2145
In Commercial Distribution

  • 00850557007782 ()
  • 00850557007799 ()
  • 10850557007796 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fourteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: COC | THC | OPI | BZO | MAMP | TCA | OXY | UP | BAR | MTD | AMP | MDMA | PCP | PPX
MERGERS MARKETING, INC.
PSC-DOA-1144
In Commercial Distribution

  • 00850557007768 ()
  • 00850557007775 ()
  • 10850557007772 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Thirteen Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR| MTD | OXY | PCP | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-2135
In Commercial Distribution

  • 00850557007720 ()
  • 00850557007737 ()
  • 10850557007734 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-6125
In Commercial Distribution

  • 00850557007683 ()
  • 00850557007690 ()
  • 10850557007697 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP
MERGERS MARKETING, INC.
PSC-DOA-8104
In Commercial Distribution

  • 00850557007669 ()
  • 00850557007676 ()
  • 10850557007673 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BAR | BUP | BZO | COC | MET | MTD | OPI | OXY | TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7104
In Commercial Distribution

  • 00850557007621 ()
  • 00850557007638 ()
  • 10850557007635 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-4104
In Commercial Distribution

  • 00850557007584 ()
  • 00850557007591 ()
  • 10850557007598 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-3104
In Commercial Distribution

  • 00850557007508 ()
  • 00850557007515 ()
  • 10850557007512 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
External quality controls to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 fusion gene using molecular test systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008367 ()
C240

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
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

  • 00852720008183 ()
C207

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Twelve Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MOP | MTD | OXY | PCP| TCA | THC
MERGERS MARKETING, INC.
PSC-DOA-7125
In Commercial Distribution

  • 00851000007120 ()
  • 10851000007127 ()
  • 20851000007124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting
No Description
Microgenics Corporation
10027480
In Commercial Distribution

  • 00884883007505 ()


  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
No Description
Joimax GmbH
JINTPC1105
In Commercial Distribution

  • 04250337116547 ()


  • Electromagnetic surgical navigation device tracking system
PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to monitor total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA or Plus analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
1710
In Commercial Distribution

  • 00381931710016 ()
  • 10381931710013 ()
1710

  • Multiple lipid analyte IVD, kit, spectrophotometry
Kit Vaginal Reagent COR IVD
BECTON, DICKINSON AND COMPANY
443976
In Commercial Distribution

  • 00382904439767 ()
443976

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Home Drug Test Kit 12 Panel AMP BAR BZD COC MET MOR MTD OXY PCP TCA THC XTC
CONFIRM BIOSCIENCES, INC.
RO-DR0012
In Commercial Distribution

  • 00895330002394 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
This urine test kit detects 4 drugs: Cocaine (COC), Marijuana (THC), Opiates (OPI) including Heroin, Amphetamines (AMP)
CONFIRM BIOSCIENCES, INC.
03-5201
In Commercial Distribution

  • 00895330002318 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
his kit tests for 12 Drugs including Prescription Drugs: 7 Illicit Drugs Marijuana, Cocaine, Opiates (Heroin), Methamphetamine, Ecstasy, Amphetamine, Phencyclidine (PCP) 5 Prescription Drugs Tricyclic Antidepressants, Barbiturates, Benzodiazepines, Methadone, Oxycodone
CONFIRM BIOSCIENCES, INC.
03-5202
In Commercial Distribution

  • 00895330002288 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which is easy to perform from the privacy of your home to detect marijuana usage.
CONFIRM BIOSCIENCES, INC.
03-5601
In Commercial Distribution

  • 00895330002264 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It is designed for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine, Opiate, and Cannabinoid in human urine specimens.
DRG International Inc
RAP-3773
Not in Commercial Distribution

  • 00840239037732 ()
RAP-3773

  • Multiple drugs of abuse IVD, kit, thin layer chromatography
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
20-006-001
Not in Commercial Distribution

20-006-001

  • Multiple coagulation factor IVD, kit, clotting
No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
424803
In Commercial Distribution

  • 00815381021007 ()


  • Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424461
In Commercial Distribution

  • 00815381020659 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0137
Not in Commercial Distribution

  • 00815381020307 ()
RFIT-ASY-0137

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0136
Not in Commercial Distribution

  • 00815381020291 ()
RFIT-ASY-0136

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Aktina Corp.
11-215
In Commercial Distribution

  • B365112150 ()


  • Indexed-immobilization patient positioning system
Maxx Power Elevating/Articulating Calf Panel (Upper) Assembly. Optional Elevating Calf Panel (includes foam pad), may be used on its own, or in combination with the Power Down Foot Platform. Assembly includes actuator motor. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0229-PEACP
In Commercial Distribution

  • 07540147002459 ()
PEACP

  • Wheelchair footrest/legrest
Power Elevating Calf Panel Assy with optional Latitude Foot Platform. Optional Elevating Calf Panel Assy is available with or without a foot platform. (Optional Foot Platform Foam Pad available in Onyx (faux vinyl fabric), or standard polyester fabric. Assembly includes actuator motor. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0229-PECP
In Commercial Distribution

  • 07540147002442 ()
PECP

  • Wheelchair footrest/legrest
No Description
GLOBAL SURGICAL CORPORATION
M 547FSWMB
In Commercial Distribution

  • 00810040251023 ()


  • General-purpose surgical microscope
Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.
Opgen, Inc.
CP3230
Not in Commercial Distribution

  • 10812125010010 ()
CP3230

  • Microplate IVD
Conductive Body & Leg Restraint Strap, Has 5"Wide Panel Attached to a 2"Wide Strap with 2 Airplane Style Buckles, 0.5" Thick Pressure Relief Padding Sewn onto Center Panel, Without Side Rail Hooks, Adjustable to 96"
Coulmed Products Group LLC
153-1WOH-PR
In Commercial Distribution

  • 10810087353046 ()
153-1WOH-PR

  • Limb/torso/head restraint, reusable
Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.
Opgen, Inc.
CP3230
Not in Commercial Distribution

  • 00812125010013 ()
CP3230

  • Microplate IVD
The A-Series Spindle Single Light Single Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190279 ()
LAS000004

  • Medical monitor/light mount
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