SEARCH RESULTS FOR: ✔️❤️최신주식%E(34281 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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CARDINAL HEALTH - 10195594363581

D AND E 2ND TRIMESTER PACK
Cardinal Health 200, LLC
SMA31DE452
In Commercial Distribution

  • 50195594363589 ()
  • 10195594363581 ()
SMA31DE452

  • Obstetrical/gynaecological surgical procedure kit, medicated

CARDINAL HEALTH - 10195594355814

C E T, HUFFMAN CATARACT PACK
Cardinal Health 200, LLC
SEY32CELCC
In Commercial Distribution

  • 50195594355812 ()
  • 10195594355814 ()
SEY32CELCC

  • General surgical procedure kit, medicated

Newport - 10884521540934

e360 Ventilator with Accessories;E Model
Newport Medical Instruments, Inc.
E360E-ES-NA
Not in Commercial Distribution

  • 10884521540934 ()


  • Neonatal/adult intensive-care ventilator

NA - 00199150029044

CUSTOM PACK BB11H15R3 CONNECT E CL
MEDTRONIC, INC.
BB11H15R3
In Commercial Distribution

  • 00199150029044 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00199150029006

CUSTOM PACK BB7U79R14 3/8 E
MEDTRONIC, INC.
BB7U79R14
In Commercial Distribution

  • 00199150029006 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00199150027118

CUSTOM PACK BB12P85R 5PK E ACCESSORY
MEDTRONIC, INC.
BB12P85R
In Commercial Distribution

  • 20199150027129 ()
  • 00199150027118 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00199150026654

CUSTOM PACK BB11E82R2 CB E SUPP
MEDTRONIC, INC.
BB11E82R2
In Commercial Distribution

  • 00199150026654 ()


  • Cardiopulmonary bypass system blood tubing set

VIVIT Supply - 10810141931401

Commend Nitrile Exam Glove, Chemo Drug Tested, Textured Fingertips, Powder-Free,
Vivit Supply LLC
20121
In Commercial Distribution

  • 20810141931408 ()
  • 10810141931401 ()
  • 00810141931404 ()


  • Total immunoglobulin E (IgE total) IVD, kit, rapid ICT, clinical

T2Bacteria® QCheck Negative Kit - M70885080743

Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885080730

Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-08073
In Commercial Distribution

  • M70885080730 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885071910

Positive SK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-07191
In Commercial Distribution

  • M70885071910 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

Thermoflect - 00612899004184

THERMOFLECT GOWN KIT E, 25 EA TS THERMOFLECT GOWN KIT E, GOWN, CAP, 25 EA NONWOVEN
Encompass Group, L.L.C.
5000-840
In Commercial Distribution

  • 10612899004181 ()
  • 00612899004184 ()


  • Hypothermia-prevention whole-body suit

Clostridium difficile (CDF) Stool Sample Preparation Kit - 00857573006362

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
30-002-022
Not in Commercial Distribution

  • 00857573006362 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Clostridium difficile (CDF) Amplification Tray - 00857573006317

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-011-022
Not in Commercial Distribution

  • 00857573006317 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Clostridium difficile (CDF) Extraction Tray - 00857573006256

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-009-022
Not in Commercial Distribution

  • 00857573006256 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Clostridium difficile (CDF) Nucleic Acid Test Cartridge - 00857573006157

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-006-022
Not in Commercial Distribution

  • 00857573006157 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Amplification Tray - 00857573006089

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution

  • 00857573006089 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Stool Sample Preparation Kit - 00857573006065

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
30-002-023
Not in Commercial Distribution

  • 00857573006065 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Extraction Tray - 00857573006058

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-009-023
Not in Commercial Distribution

  • 00857573006058 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Nucleic Acid Test Cartridge - 00857573006041

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-006-023
Not in Commercial Distribution

  • 00857573006041 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

BioCode MDx 3000 Optical Calibration and Verification Kit - 00851034007028

Kit containing calibrators and controls for MDx 3000.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007028 ()
64-C0002

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, calibrator

Gastrointestinal Pathogen Panel (GPP) Kit - 00851034007011

In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Helix Elite™ Molecular Standards: Inactivated Standard - 10845357042016

Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
MICROBIOLOGICS INC.
HE0027N
In Commercial Distribution

  • 10845357042016 ()
HE0027N

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041965

Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA
MICROBIOLOGICS INC.
HE0025S
Not in Commercial Distribution

  • 10845357041965 ()
HE0025S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041873

Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA
MICROBIOLOGICS INC.
HE0015S
Not in Commercial Distribution

  • 10845357041873 ()
HE0015S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041859

Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA
MICROBIOLOGICS INC.
HE0013S
In Commercial Distribution

  • 10845357041859 ()
HE0013S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041842

Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA
MICROBIOLOGICS INC.
HE0012S
In Commercial Distribution

  • 10845357041842 ()
HE0012S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041798

Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA
MICROBIOLOGICS INC.
HE0007S
Not in Commercial Distribution

  • 10845357041798 ()
HE0007S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041781

Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA
MICROBIOLOGICS INC.
HE0006S
Not in Commercial Distribution

  • 10845357041781 ()
HE0006S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041774

Helix Elite™ Molecular Standards Giardia lamblia Synthetic DNA
MICROBIOLOGICS INC.
HE0005S
Not in Commercial Distribution

  • 10845357041774 ()
HE0005S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041767

Helix Elite™ Molecular Standards Encephalitozoon intestinalis Synthetic DNA
MICROBIOLOGICS INC.
HE0004S
Not in Commercial Distribution

  • 10845357041767 ()
HE0004S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041750

Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA
MICROBIOLOGICS INC.
HE0003S
Not in Commercial Distribution

  • 10845357041750 ()
HE0003S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041743

Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA
MICROBIOLOGICS INC.
HE0002S
Not in Commercial Distribution

  • 10845357041743 ()
HE0002S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041736

Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA
MICROBIOLOGICS INC.
HE0001S
Not in Commercial Distribution

  • 10845357041736 ()
HE0001S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Clostridium difficile (CDF) Stool Sample Preparation Kit - 00840487101735

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
30-002-022
In Commercial Distribution

30-002-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Clostridium difficile (CDF) Amplification Tray - 00840487101704

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-011-022
In Commercial Distribution

20-011-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Clostridium difficile (CDF) Extraction Tray - 00840487101650

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-009-022
In Commercial Distribution

20-009-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Clostridium difficile (CDF) Nucleic Acid Test Cartridge - 00840487101605

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-006-022
In Commercial Distribution

20-006-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Stool Sample Preparation Kit - 00840487101568

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
30-002-023
In Commercial Distribution

30-002-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Enteric Pathogens (EP) Extraction Tray - 00840487101551

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-009-023
In Commercial Distribution

20-009-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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