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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 Class Implantable

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App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
Not in Commercial Distribution

  • 00810096640130 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
APIFIX LTD
MID-C 125
In Commercial Distribution

  • 07290018128046 ()


  • Spinal distraction rod, mechanical
No Description
APIFIX LTD
MID-C 115
In Commercial Distribution

  • 07290018128039 ()


  • Spinal distraction rod, mechanical
No Description
APIFIX LTD
MID-C 105
In Commercial Distribution

  • 07290018128022 ()


  • Spinal distraction rod, mechanical
No Description
APIFIX LTD
MID-C 95
In Commercial Distribution

  • 07290018128015 ()


  • Spinal distraction rod, mechanical
No Description
APIFIX LTD
MID-C 85
In Commercial Distribution

  • 07290018128008 ()


  • Spinal distraction rod, mechanical
The HPX Gas Handling Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows for two Xenon Xe 129 Gas Blend cylinders, one NF-grade UHP nitrogen cylinder and one industrial nitrogen cylinder to be connected to the HPX Hyperpolarizer.
Polarean, Inc.
Rev E
In Commercial Distribution

  • 00850045949037 ()
45660

  • Lung MRI xenon hyperpolarization system
The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
IMPLANT SOLUTIONS PTY LTD
1
In Commercial Distribution

  • D102BAR0 ()


  • Dental implant suprastructure, permanent, custom-made
  • Dental implant suprastructure, temporary, custom-made
Emergency Preparedness First Aid Kit Item#3557 Features: Vinyl case with zipper Includes a 12-hour safety light stick, 10 latex-free bandages, 5 snip bandages, two 2" x 3" adhesive pads, 2 knuckle bandages, 5 antiseptic towelettes, 5 first aid cream packets, 2 non-adhesive pads, 1 gauze roll, 1 roll of adhesive tape, and 1 first aid guide
EVANS MANUFACTURING, INC.
3557
In Commercial Distribution

  • G40935570 ()
3557

  • First aid kit, medicated
The lmmuView® COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The lmmuView® COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the lmmuView® COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be
CTK BIOTECH INC.
R0182CHT-20T
In Commercial Distribution

  • 00855402007979 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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