SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)

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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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Varex Digital Imaging System, Nexus, DRF, v3.2.0 - 00854344007443

No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.2.0
In Commercial Distribution

  • 00854344007443 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging System, Nexus, DRF, v3.1.0 - 00854344007429

No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.1.0
In Commercial Distribution

  • 00854344007429 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Imaging Nexus DRF Digital X-ray Imaging System - 00854344007276

No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007276 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Imaging Nexus DRF Imaging Software - 00854344007269

No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007269 ()


  • X-ray system computer, diagnostic, general-purpose

Nexus DRF, Digital Imaging Software - 00854344007245

No Description
VAREX IMAGING CORPORATION
v3.1.1
In Commercial Distribution

  • 00854344007245 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor - 00854344007054

No Description
VAREX IMAGING CORPORATION
Nexus-DRF
In Commercial Distribution

  • 00854344007054 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging Software, Nexus, DRF, v2.5 - 00854344007023

No Description
VAREX IMAGING CORPORATION
Nexus, DRF, v2.5
In Commercial Distribution

  • 00854344007023 ()


  • X-ray system computer, diagnostic, general-purpose

Radiology Information Systems, Inc. - 00860009490604

PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation

InfiMed Nexus, DRF, v2.5 - 00858086006122

No Description
INFIMED, INC.
2.5
Not in Commercial Distribution

  • 00858086006122 ()


  • X-ray system computer, diagnostic, general-purpose

InfiMed Nexus, RF/DR, Digital Receptor - 00858086006030

No Description
INFIMED, INC.
Nexus-DRF
Not in Commercial Distribution

  • 00858086006030 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging Software, Nexus DRF, v3.5 - 00810751030252

No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose

Local Run Manager CF 139-Variant 2.0 Micro Analysis Module - 00816270020378

The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072975
In Commercial Distribution

  • 00816270020378 ()
20072975

  • Cystic fibrosis IVD, kit, multiplex

Local Run Manager CF 139 Variant Analysis Module - 00816270020286

The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis 139-Variant Assay.
ILLUMINA, INC.
20047009
In Commercial Distribution

  • 00816270020286 ()
20047009

  • Cystic fibrosis IVD, kit, multiplex

MiSeqDx CF 139 Variant Assay (2 Run) - 00816270020019

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A 15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B 15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5 15041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5 15041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A 15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B 15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/5 15041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5
ILLUMINA, INC.
15036580
Not in Commercial Distribution

  • 00816270020019 ()
DX-102-1004

  • Cystic fibrosis IVD, kit, multiplex

SEDECAL - 08436046001527

This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-50HF-B-D-C
In Commercial Distribution

  • 08436046001527 ()


  • Mobile basic diagnostic x-ray system, digital

dicomPACS®DX-R - 04250802900411

Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
5
Not in Commercial Distribution

  • 04250802900411 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software

dicomPACS®DX-R - 04250802900404

Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
4.3
Not in Commercial Distribution

  • 04250802900404 ()
SW1000

  • Basic diagnostic x-ray system application software
  • Radiology DICOM image processing application software
  • Diagnostic x-ray digital imaging system workstation application software

dicomPACS®DX-R - 04250802900015

Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
8
In Commercial Distribution

  • 04250802900015 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software

Duet DRF - 03701440100035

No Description
THALES AVS FRANCE SAS
63111976
In Commercial Distribution

  • 03701440100035 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

ArtPIX DRF - 07290012104909

No Description
C.M.T. MEDICAL TECHNOLOGIES LTD.
63627589
In Commercial Distribution

  • 07290012104909 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital

Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - 00857573006027

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

Birlinn BCR-ABL1 p210 IS Control Panel C240 - 00852720008367

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

Xpert BCR-ABL IS p210 Linearity Panel C207 - 00852720008183

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

Thirteen Panel Clear Scan Drug Test Cup - 00850557007980

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 - 00850557007966

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 - 00850557007942

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 - 00850557007928

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 - 00850557007904

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) - 00850557007782

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) - 00850557007768

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) - 00850557007720

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) - 00850557007683

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) - 00850557007669

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) - 00850557007621

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) - 00850557007584

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) - 00850557007508

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

Twelve Panel PreScreen Plus Cup (CLIA Waived) - 00851000007120

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

MAS Omni Infectious BSI Positive Control Panel - 00884883007505

No Description
Microgenics Corporation
10027480
In Commercial Distribution

  • 00884883007505 ()


  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Enterovirus Panel Antigen Control Slide, 4 wells - B110QEP66040

No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control

ReliOn Home Drug Test Kit 12 Panel - 00895330002394

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

DrugConfirm™ 4 Panel Instant Drug Test - 00895330002318

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

DrugConfirm™ 12 Panel Instant Drug Test - 00895330002288

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™ Single Panel Marijuana Testing Kit - 00895330002264

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

Joimax® Intracs® EM Panel PC - 04250337116547

No Description
Joimax GmbH
JINTPC1105
In Commercial Distribution

  • 04250337116547 ()


  • Electromagnetic surgical navigation device tracking system

PTS Panels® Lipid Panel Test Strips - 00381931710016

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

BD Vaginal Panel on BD COR System - 00382904439767

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)

Drugs of Abuse Five (5) Panel Test - 00840239037732

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

Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - 00840487101513

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

Power Elevating/Articulating Calf Panel (Upper Assy) - 07540147002459

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- Latitude Style - 07540147002442

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
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