SEARCH RESULTS FOR: hibcc(137 results)

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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

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 - B115ABCASS1CANAO1

No Description
ADVIN BIOTECH, INC.
ABCass(1)-CAN-AO
In Commercial Distribution

  • B115ABCASS1CANAO1 ()
  • B115ABCASS1CANAO2 ()


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

STRADIS HEALTHCARE - M7526894270

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

  • M7526894270 ()
  • M7526894271 ()


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

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

Accula SARS-CoV-2 Test - B540COV41000

The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
MESA BIOTECH, INC.
COV4100
In Commercial Distribution

  • B540COV41000 ()
COV4100

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

PRO1TEK 2+Patient Specialty IFAK Kit - B283PTOXFIFAK010

PRO1TEK 2+ Patient Specialty IFAK Kit - Contains Bleeding Control tools with the addition of a Hemostatic Dressing and other Trauma Kit and First-Aid Equipment.
Pro1tek
B283PTOXFIFAK010
In Commercial Distribution

  • B283PTOXFIFAK010 ()


  • First aid kit, medicated

Poly Spot - B3437000C21

Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions. There are 8 LEDs to provide a treatment area of 4 sq. cm. Batery powered with a charger
Medtek Lighting Corporation
7000C2
In Commercial Distribution

  • B3437000C21 ()

  • Area/Surface Area: 4 Square centimeter


  • Blue/red/infrared phototherapy lamp

Poly Go - B3437000C1

Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and Infrared (850nm), help to mitigate a variety of skin conditions. There are 48 LEDs to provide a treatment area of 26 square cm. Battery powered with a charger.
Medtek Lighting Corporation
7000C
In Commercial Distribution

  • B3437000C1 ()


  • Blue/red/infrared phototherapy lamp
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