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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 Class Implantable

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QuickProfile™ 2019-nCoV IgG/IgM Antibody Test - M90171108B0

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

STRADIS HEALTHCARE - M7526894270

No Description
STRADIS MEDICAL, LLC
689-427
Not in Commercial Distribution

  • M7526894270 ()
  • M7526894271 ()


  • General surgical procedure kit, non-medicated, single-use

Aligned Medical Solutions - B098PS1000

Cord Blood Collection Set
Aligned Medical Solutions
PS100
In Commercial Distribution

  • B098PS1001 ()
  • B098PS1000 ()
PS100

  • Umbilical cord blood collection set

Advin COVID-19 Antigen Test @Home - B115ABCASS5CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(5)-CAN-AO
In Commercial Distribution

  • B115ABCASS5CANAO1 ()
  • B115ABCASS5CANAO0 ()


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

Advin COVID-19 Antigen Test @Home - B115ABCASS2CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(2)-CAN-AO
In Commercial Distribution

  • B115ABCASS2CANAO1 ()
  • B115ABCASS2CANAO0 ()


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

Safety Made - G232T611

First aid kit with items to help treat minor injuries
Live Safely Products, Inc.
T61
In Commercial Distribution

  • G232T611 ()


  • First aid kit, medicated

Safety Made - G232SM7191911

First aid kit with items to help treat minor injuries
Live Safely Products, Inc.
SM71919-1
In Commercial Distribution

  • G232SM7191911 ()


  • First aid kit, medicated

Safety Made - G232SM4232111

First aid kit with items to help treat minor injuries
Live Safely Products, Inc.
SM42321-1
In Commercial Distribution

  • G232SM4232111 ()


  • First aid kit, medicated

Safety Made - G232S751

First aid kit with items to help treat minor injuries
Live Safely Products, Inc.
S75
In Commercial Distribution

  • G232S751 ()


  • First aid kit, medicated

Safety Made - G232S1251

First aid kit with items to help treat minor injuries
Live Safely Products, Inc.
S125
In Commercial Distribution

  • G232S1251 ()


  • First aid kit, medicated
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