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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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First Aid Kit containing Drugs OTC and Medical Devices class I: Woven, Adhesive tape, Nitrile Gloves, Antiseptic Towelettes, Survival Blanket, Scissor bandage, Splinter Forceps, Bandage compress, CPR Mask, Triangular bandage, Gauze pads.
North Safety de Mexicali, S. de R. L. de C.V.
SF00001996
In Commercial Distribution

  • 00883940051529 ()


  • First aid kit, medicated
D AND C PACK
Cardinal Health 200, LLC
SMA3DDCMM3
In Commercial Distribution

  • 50195594048226 ()
  • 10195594048228 ()
SMA3DDCMM3

  • Obstetrical/gynaecological surgical procedure kit, medicated
D AND C GYN PACK
Cardinal Health 200, LLC
SMA54DCEL1
In Commercial Distribution

  • 50195594052063 ()
  • 10195594052065 ()
SMA54DCEL1

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
HEART PROGRAM BAG
CENTURION MEDICAL PRODUCTS CORPORATION
SB1335
In Commercial Distribution

  • 50653160089863 ()
  • 00653160089868 ()
SB1335

  • First aid kit, non-medicated, single-use
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
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-5T
In Commercial Distribution

  • 00855402007962 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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-2T
In Commercial Distribution

  • 00855402007955 ()
R0182CHT

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
Gary Plastic Packaging Corp.
DS551TC3
In Commercial Distribution

  • 00661948500153 ()
DS551TC3

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
PZ600-A-CK
In Commercial Distribution

  • 00661948011246 ()
PZ600-A-CK

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
TXB5KQ
In Commercial Distribution

  • 00661948008536 ()
TXB5KQ

  • First aid kit, medicated
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