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 Class Implantable

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QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
No Description
STRADIS MEDICAL, LLC
689-427
Not in Commercial Distribution

  • M7526894270 ()
  • M7526894271 ()


  • General surgical procedure kit, non-medicated, single-use
Cord Blood Collection Set
Aligned Medical Solutions
PS100
In Commercial Distribution

  • B098PS1001 ()
  • B098PS1000 ()
PS100

  • Umbilical cord blood collection set
No Description
ADVIN BIOTECH, INC.
ABCass(2)-CAN-AO
In Commercial Distribution

  • B115ABCASS2CANAO1 ()
  • B115ABCASS2CANAO0 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
ADVIN BIOTECH, INC.
ABCass(5)-CAN-AO
In Commercial Distribution

  • B115ABCASS5CANAO1 ()
  • B115ABCASS5CANAO0 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
AEMT KIT SWAT-T Tourniquet 1 ea Celox Rapid 1 ea Duct Tape 1 ea
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M6898811201010 ()
88-112-01

  • First aid kit, non-medicated, single-use
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M68984497010 ()
84-497

  • First aid kit, medicated
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M68984493010 ()
84-493

  • First aid kit, medicated
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M6898444601010 ()
84-446-01

  • First aid kit, medicated
Equips trained medical first responders with a higher density of the core components identified by the CoTCCC as required to provide lifesaving interventions through buddy-aid and medical aid tasks during the Tactical Field Care phase of care. • The system is color coded and sequentially organized for rapid visual and muscle • memory identification of the appropriate tool required under the MARCH protocol. • The system has an “open architecture” which allows the introduction of emerging technologies that improve the lifesaving capabilities of the individual.
Safeguard US Operating, LLC
01
Not in Commercial Distribution

  • M68984443010 ()
84-443

  • First aid kit, medicated
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