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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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FilmArray® Respiratory Panel 2 (RP2) - 00815381020154

IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0129
Not in Commercial Distribution

  • 00815381020154 ()
RFIT-ASY-0129

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Respiratory Panel (RP) EZ - 00815381020147

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Respiratory Panel (RP) - 00815381020079

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Respiratory Panel (RP) - 00815381020062

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Dealmed - 00817415020963

Strep A Test CLIA Waived 25/Box
DEALMED MEDICAL SUPPLIES LLC
788025
In Commercial Distribution

  • 00817415020307 ()
  • 00817415020963 ()
788025

  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

QIAstat-Dx® Respiratory Panel Mini - 04053228048862

No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228048862 ()
691218

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

QIAstat-Dx® Respiratory Panel Plus - 04053228047438

No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228047438 ()
691224

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

QIAstat-Dx® Respiratory Panel - 04053228033905

No Description
QIAGEN GmbH
V1
Not in Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

NA - 00841379158325

LAMINA HOOK, MEDIUM, NARROW
HYHTE HOLDINGS, INC.
AFAA0NMS0
In Commercial Distribution

  • 00841379158325 ()

  • NARROW
  • MEDIUM
AFAA0NMS0

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Group B Streptococcus Detection Kit(Immunochromatography) - 06974849369137

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369137 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

Group B Streptococcus Detection Kit(Immunochromatography) - 06974849369120

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
5 tests/kit
In Commercial Distribution

  • 06974849369120 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

GeneXpert® - 07332940008604

Xpert Xpress CoV-2/Flu/RSV plus
CEPHEID
XPRS4PLEX-10
In Commercial Distribution

  • 07332940008604 ()
XPRS4PLEX-10

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Idylla™ Respiratory (IFV-RSV) Panel - 15415219000635

No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Influenza Virus A IgG ELISA - 00404847437935

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
Not in Commercial Distribution

  • 00404847437935 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza Virus A IgG ELISA - 00840239037930

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3793
In Commercial Distribution

  • 00840239037930 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics™ Influenza A and B DFA Kit - 08436037124594

Influenza A and B DFA Kit
EMD Millipore Corporation
3123
Not in Commercial Distribution

  • 08436037124594 ()
3123

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

HemosIL Routine Control Level 3 - 08426950573401

HemosIL Routine Control Level 3
INSTRUMENTATION LABORATORY COMPANY
00020005800
In Commercial Distribution

  • 08426950573401 ()
  • 18426950573408 ()
00020005800

  • Multiple coagulation factor IVD, control

HemosIL Routine Control Level 2 - 08426950573395

HemosIL Routine Control Level 2
INSTRUMENTATION LABORATORY COMPANY
00020005700
In Commercial Distribution

  • 08426950573395 ()
  • 18426950573392 ()
00020005700

  • Multiple coagulation factor IVD, control

HemosIL Routine Control Level 1 - 08426950573388

HemosIL Routine Control Level 1
INSTRUMENTATION LABORATORY COMPANY
00020005600
In Commercial Distribution

  • 08426950573388 ()
  • 18426950573385 ()
00020005600

  • Multiple coagulation factor IVD, control

HemosIL UF Heparin Controls - 08426950478683

HemosIL UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control

Influenza A IgG ELISA Test Kit - B350GSD0130090

Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza A Negative Control - B110IAN11100

No Description
Bion Enterprises, Ltd.
IAN-1110
In Commercial Distribution

  • B110IAN11100 ()
IAN-1110

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control

Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System - B110IA11120

No Description
Bion Enterprises, Ltd.
IA-1112
In Commercial Distribution

  • B110IA11120 ()
IA-1112

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, reagent

Influenza A IgG Control - B110IAG11200

No Description
Bion Enterprises, Ltd.
IAG-1120
In Commercial Distribution

  • B110IAG11200 ()
IAG-1120

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control

Influenza Virus A IgG ELISA - 04048474037937

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
In Commercial Distribution

  • 04048474037937 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Influenza A Virus ELISA (IgM) - 04049016028307

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

  • 04049016028307 ()


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

Anti-Influenza A Virus ELISA (IgG) - 04049016028291

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 G
In Commercial Distribution

  • 04049016028291 ()


  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Influenza A Virus ELISA (IgA) - 04049016028284

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

  • 04049016028284 ()


  • Influenza A virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

IMAGEN Respiratory Screen Kit - 05032384503841

No Description
OXOID LIMITED
K612011-2
In Commercial Distribution

  • 05032384503841 ()


  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

IMAGEN RESPIRATORY SCREEN POS CON SLIDE - 05032384503070

No Description
OXOID LIMITED
S612130-2
In Commercial Distribution

  • 05032384503070 ()


  • Multiple-genus respiratory virus antigen IVD, control

Light Diagnostics ™ Influenza A & B Control Slides - 04053252373435

Influenza A & B Control Slides
EMD Millipore Corporation
5010-5
Not in Commercial Distribution

  • 04053252373435 ()
5010-5

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ SimulFluor® Flu A/Flu B Reagent - 04053252368165

SimulFluor® Flu A/Flu B Reagent
EMD Millipore Corporation
5250
Not in Commercial Distribution

  • 04053252368165 ()
5250

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay - 04053252367588

SimulFluor® Flu A/Flu B Immunofluorescence Assay
EMD Millipore Corporation
3121
Not in Commercial Distribution

  • 04053252367588 ()
3121

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics ™ Influenza B Monoclonal Antibody - 04053252330094

Influenza B Monoclonal Antibody
EMD Millipore Corporation
5002
Not in Commercial Distribution

  • 04053252330094 ()
5002

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal Antibody - 04053252320439

Influenza A FITC-Labeled Monoclonal Antibody
EMD Millipore Corporation
5017
Not in Commercial Distribution

  • 04053252320439 ()
5017

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent - 04053252270239

SimulFluor® Flu A / Flu B Reagent
EMD Millipore Corporation
5250-5ML
Not in Commercial Distribution

  • 04053252270239 ()
5250-5ML

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics ™ Influenza A & B Control Slide - 04053252789229

Influenza A & B Control Slide
EMD Millipore Corporation
5010
Not in Commercial Distribution

  • 04053252789229 ()
5010

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ Influenza B Monoclonal Antibody - 04053252473722

Influenza B Monoclonal Antibody
EMD Millipore Corporation
5018
Not in Commercial Distribution

  • 04053252473722 ()
5018

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ Influenza A Monoclonal Antibody - 04053252470226

Influenza A Monoclonal Antibody
EMD Millipore Corporation
5001
Not in Commercial Distribution

  • 04053252470226 ()
5001

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Duet - 30014613330882

D3 Duet DFA Influenza A/Respiratory Virus Screening kit
DIAGNOSTIC HYBRIDS, INC.
01-200000
In Commercial Distribution

  • 30014613330882 ()
01-200000

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
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