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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X-ray Flat Panel Detector - 06970597830363

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750Cw
In Commercial Distribution

  • 06970597830363 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830349

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750C
In Commercial Distribution

  • 06970597830349 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830271

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800RF
In Commercial Distribution

  • 06970597830271 ()


  • Stationary basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830257

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cw
In Commercial Distribution

  • 06970597830257 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830240

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800L
In Commercial Distribution

  • 06970597830240 ()


  • Stationary basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830219

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800R
In Commercial Distribution

  • 06970597830219 ()


  • Stationary basic diagnostic x-ray system, digital

X-ray Flat Panel Detectors - 06970597830172

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cwe
In Commercial Distribution

  • 06970597830172 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830097

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cw
In Commercial Distribution

  • 06970597830097 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830073

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500L
In Commercial Distribution

  • 06970597830073 ()


  • Stationary basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830066

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500C
In Commercial Distribution

  • 06970597830066 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830035

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500P
In Commercial Distribution

  • 06970597830035 ()


  • Portable basic diagnostic x-ray system, digital

Pocguide Multi-Drug Test Panel - 06978151200058

Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP1000/BAR300/BUP10/BZO300/COC300/EDDP300/MET1000/MDMA500/OPI2000/MTD300/OXY100/PCP25/TCA1000/THC50THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200058 ()


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

Pocguide Multi-Drug Test Panel - 06978151200034

Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MET500/MDMA500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200034 ()


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

Pocguide Multi-Drug Test Panel - 06978151200010

Pocguide Multi-Drug Test Panel (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200010 ()


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

AssureTech Panel Dip Tests - 06952804830212

AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804830212 ()


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

AssureTech Panel Dip Tests - 06952804802646

12 Strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802646 ()


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

AssureTech Panel Dip Tests - 06952804802622

15 strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802622 ()


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

AssureTech Panel Dip Tests - 06952804802608

15 Strips, including MOR300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802608 ()


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

AssureTech Panel Dip Tests - 06952804801656

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801656 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical

Buprenorphine/Methadone Panel Dip - 06952804801397

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801397 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical

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

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

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

Respiratory Virus Plus (RV+) Amplification Tray - 00857573006294

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)

Respiratory Virus Plus (RV+) Extraction Tray - 00857573006232

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)

Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge - 00857573006133

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)

FILMARRAY - 00851458005112

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 - 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 - 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 - 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 - 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)

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

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)

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 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
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