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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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Silaris Influenza A&B Test - B54010270

The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
MESA BIOTECH, INC.
1027
In Commercial Distribution

  • B54010270 ()
1027

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Coxsackie B1-B6 Negative Control - B110CBN33100

No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control

Coxsackie B1-B6 IgG Control - B110CBG33200

No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control

Bausch + Lomb - 00757770411610

FCP INCUS WIRE CLOSURE MCGEE
Bausch & Lomb Incorporated
N1685 D 1
In Commercial Distribution

  • 00757770411610 ()
N1685 D 1

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Xpert Xpress Flu - 07332940006044

Xpert Xpress Flu kit; 10 test kit
CEPHEID
XPRSFLU-10
In Commercial Distribution

  • 07332940006044 ()
XPRSFLU-10

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert Flu - 07332940001070

Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Anti-Influenza A/B Virus Pool ELISA (IgM) - 04049016096764

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601-1 M
Not in Commercial Distribution

  • 04049016096764 ()


  • Influenza A/B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

IFA Mosaic: Coxsackie virus A Types (IgG) - 04049016080787

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2010-2 G
In Commercial Distribution

  • 04049016080787 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) - 04049016061472

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-4 G
In Commercial Distribution

  • 04049016061472 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus A Types (IgG) - 04049016061151

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-2 G
In Commercial Distribution

  • 04049016061151 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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