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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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HardyCHROM™ ESBL A chromogenic medium for use as a primary screening method for the detection and differentiation of Extended-Spectrum Beta-Lactamase producing Enterobacteriaciae. Some ingredients are very light sensitive. Store and incubate in the dark.
HARDY DIAGNOSTICS
G321
In Commercial Distribution

  • 00816576023097 ()
  • 00816576023080 ()
G321

  • ESBL Enterobacteriaceae agar culture medium IVD, chromogenic
PRIME&BOND XP MINI REFILL is a universal Total-Etch Dental Adhesive. Prime&Bond XP Refill is received in a bottle delivery (D010K3027620). With its supporting accessory (Clixdish) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60667402
In Commercial Distribution

  • D010606674021 ()

  • Total Volume: 2.5 Milliliter
  • Liquid
60667402

  • Dentine adhesive
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution

  • 05060484630044 ()


  • Electrocardiography telemetric monitoring system
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7) For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)
WELL-LIFE HEALTHCARE LTD.
WL-2405
Not in Commercial Distribution

  • 04719872264057 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr Virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A92101G
In Commercial Distribution

  • 00845533000031 ()
A92101G

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution

  • 00866489000036 ()
740769

  • Pipetting system
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-005
In Commercial Distribution

  • D767B0105101 ()
  • D767B010501 ()
B01-0510

  • General oral wound dressing, non-animal-derived, sterile
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-004
In Commercial Distribution

  • D767B0105081 ()
  • D767B0104081 ()
B01-0408

  • General oral wound dressing, non-animal-derived, sterile
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-003
In Commercial Distribution

  • D767B0103081 ()
  • D767B010301 ()
B01-0308

  • General oral wound dressing, non-animal-derived, sterile
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-002
In Commercial Distribution

  • D767B0102121 ()
  • D767B010201 ()
B01-0212

  • General oral wound dressing, non-animal-derived, sterile
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