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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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Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus 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 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 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. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-25
In Commercial Distribution

  • 08800076700765 ()
  • 08800076700598 ()
COVAGHT2-U-25

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus 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 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 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. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-2
In Commercial Distribution

  • 08800076700741 ()
  • 08800076700222 ()
COVAGHT2-U-02

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.
AK Globaltech Corp
INDMP1000
In Commercial Distribution

  • 00853464001485 ()
AKG-INDMP1000

  • Alcohol breath analyser
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.
AK Globaltech Corp
INDMP
In Commercial Distribution

  • 00853464001478 ()
AKG-INDMP

  • Alcohol breath analyser
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.
AK Globaltech Corp
STDMP1000
In Commercial Distribution

  • 00853464001461 ()
AKG-STDMP1000

  • Alcohol breath analyser
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core
AK Globaltech Corp
STDMP500
In Commercial Distribution

  • 00853464001454 ()
AKG-STDMP500

  • Alcohol breath analyser
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.
AK Globaltech Corp
STDMP100
In Commercial Distribution

  • 00853464001447 ()
AKG-STDMP100

  • Alcohol breath analyser
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.
AK Globaltech Corp
STDMP20
In Commercial Distribution

  • 00853464001430 ()
AKG-STDMP20

  • Alcohol breath analyser
AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.
AK Globaltech Corp
STDMP
In Commercial Distribution

  • 00853464001423 ()
AKG-STDMP

  • Alcohol breath analyser
AlcoMate AL4000 FUEL CELL Coin-Operated Vending-Type Breathalyzer with Pre-Calibrated Replaceable Sensor Technology. Only FUEL CELL sensor modules will work with this device. Important: the device is available in coin-operation mode only (device image may not be accurate.
AK Globaltech Corp
AL4000
In Commercial Distribution

  • 00853464001386 ()
AKG-AL4000

  • Alcohol breath analyser
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