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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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ID NOW Influenza A & B 2 - 10811877010422

A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution

  • 10811877010422 ()


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

Accula Flu A / B Test - B540FAB1100CW0

The Accula™ Flu A / B Test performed on the Accula 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 Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. Accula Flu 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.
FAB1100CW
In Commercial Distribution

  • B540FAB1100CW0 ()
FAB1100CW

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

Sialris Influenza A&B Supplemental Pack - B54010350

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.
1035
In Commercial Distribution

  • B54010350 ()
1035

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

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)

Lyra - 30014613311003

Lyra FLU A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M100
In Commercial Distribution

  • 30014613311003 ()
M100

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

Solana - 30014613336068

Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution

  • 30014613336068 ()
M300

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

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)

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

Bausch + Lomb - 00757770426546

FORCEPS HARTMAN
Bausch & Lomb Incorporated
N0982
In Commercial Distribution

  • 00757770426546 ()
N0982

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

Bausch + Lomb - 00757770420636

FCP HARTMAN-HERZFELD HORIZ OPN
Bausch & Lomb Incorporated
N0970
In Commercial Distribution

  • 00757770420636 ()
N0970

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

Bausch + Lomb - 00757770417070

FORCEPS DUCKBILL
Bausch & Lomb Incorporated
N0958
In Commercial Distribution

  • 00757770417070 ()
N0958

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

Bausch + Lomb - 00757770409068

FORCEPS TOBEY
Bausch & Lomb Incorporated
N0986
In Commercial Distribution

  • 00757770409068 ()
N0986

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

Bausch + Lomb - 00757770408368

FCP HARTMAN-HERZFELD 3MM CUP
Bausch & Lomb Incorporated
N0965
In Commercial Distribution

  • 00757770408368 ()
N0965

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

Bausch + Lomb - 00757770406227

FORCEPS NOYES FINE
Bausch & Lomb Incorporated
N0950
In Commercial Distribution

  • 00757770406227 ()
N0950

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

Bausch + Lomb - 00757770405077

FCP HARTMAN-HERZFELD 2.0MM CUP
Bausch & Lomb Incorporated
N0964
In Commercial Distribution

  • 00757770405077 ()
N0964

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

Bausch + Lomb - 00757770404575

FORCEPS EAR DRESSING LUCAE STD
Bausch & Lomb Incorporated
N0902
In Commercial Distribution

  • 00757770404575 ()
N0902

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

Bausch + Lomb - 00757770407712

FENEST'TR GUILFRD-WGHT NEW ANG
Bausch & Lomb Incorporated
X0750 21
In Commercial Distribution

  • 00757770407712 ()
X0750 21

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

AMC - 00849593013796

Cable,ECG,Shielded,3 Lead,AAMI,DS com, 10'
Advantage Medical Electronics, LLC
CB-73340R
In Commercial Distribution

  • 00849593013796 ()


  • Electrical-only medical device connection cable, reusable

MEDI - 00636257002575

***DISC*JUXTALITE HD 28 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33024017
Not in Commercial Distribution

  • 00636257002575 ()


  • Compression bandaging kit

MEDI - 00636257002544

***DISC*JUXTALITE HD 33 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33036017
Not in Commercial Distribution

  • 00636257002544 ()


  • Compression bandaging kit

MEDI - 00636257002520

***DISC*JUXTALITE HD 33 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33035017
Not in Commercial Distribution

  • 00636257002520 ()


  • Compression bandaging kit

MEDI - 00636257002506

***DISC*JUXTALITE HD 33 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33034017
Not in Commercial Distribution

  • 00636257002506 ()


  • Compression bandaging kit

MEDI - 00636257002490

***DISC*JUXTALITE HD 33 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33033017
Not in Commercial Distribution

  • 00636257002490 ()


  • Compression bandaging kit

MEDI - 00636257002469

***DISC*JUXTALITE HD 28 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33026017
Not in Commercial Distribution

  • 00636257002469 ()


  • Compression bandaging kit

MEDI - 00636257002445

***DISC*JUXTALITE HD 28 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33025017
Not in Commercial Distribution

  • 00636257002445 ()


  • Compression bandaging kit

MEDI - 00636257002421

***DISC*JUXTALITE HD 28 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33023017
Not in Commercial Distribution

  • 00636257002421 ()


  • Compression bandaging kit

MASEL Buccal Tubes - 00190707102791

BT 022 ROTH COM CV GING UR DB (10)
ORTHO ORGANIZERS, INC.
4016-362-10
In Commercial Distribution

  • 00190707102791 ()


  • Orthodontic tube

MASEL Buccal Tubes - 00190707102784

BT 018 ROTH COM CV GING UL DB (10)
ORTHO ORGANIZERS, INC.
4016-361-10
In Commercial Distribution

  • 00190707102784 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087739

.022 UL6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-363-10
In Commercial Distribution

  • 00190707087739 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087722

.018 UR6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-360-10
In Commercial Distribution

  • 00190707087722 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087562

.022 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-263-10
In Commercial Distribution

  • 00190707087562 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087555

.022 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-262-10
In Commercial Distribution

  • 00190707087555 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087548

.018 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-261-10
In Commercial Distribution

  • 00190707087548 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087531

.018 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-260-10
In Commercial Distribution

  • 00190707087531 ()


  • Orthodontic tube

3-LD Set, PINCH to TWIN, A, 29, TEL COM - 00840828148764

3-LD Set, PINCH to TWIN, A, 29, TEL COM
CURBELL MEDICAL PRODUCTS, INC.
LW-3300029/3AT
In Commercial Distribution

  • 00840828148764 ()
9233

  • Electrocardiographic lead set, reusable

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 Type A7 / Type B1 (IgG) - 04049016061489

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1010-4 G
In Commercial Distribution

  • 04049016061489 ()


  • 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 B Types (IgG) - 04049016061335

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-3 G
In Commercial Distribution

  • 04049016061335 ()


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

IFA Mosaic: Coxsackie virus B Types (IgG) - 04049016061311

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-3 G
In Commercial Distribution

  • 04049016061311 ()


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

IFA Mosaic: Coxsackie virus A Types (IgG) - 04049016061175

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-2 G
In Commercial Distribution

  • 04049016061175 ()


  • 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

IFA Mosaic: Coxsackie virus (IgG) - 04049016060994

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-1 G
In Commercial Distribution

  • 04049016060994 ()


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

Anti-Influenza A/B Virus Pool ELISA (IgG) - 04049016028321

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

  • 04049016028321 ()


  • Influenza A/B virus immunoglobulin G (IgG) 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

MultiCode® Influenza B Primers - 00840487101285

Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3905
Not in Commercial Distribution

  • 00840487101285 ()
3905

  • Influenza B virus nucleic acid IVD, reagent

RSV Positive Control - 00840733103476

RSV Positive Control is an external control reagent to be used with TRU RSV Test Kits as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
751110
In Commercial Distribution

  • 00840733103476 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control

FLU/RSV Positive Control - 00840733101977

FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
MERIDIAN BIOSCIENCE, INC.
751110
Not in Commercial Distribution

  • 00840733101977 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control

IMMAGE - 15099590233242

IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
Beckman Coulter, Inc.
447480
In Commercial Distribution

  • 15099590233242 ()
447480

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, enzyme immunoassay (EIA)
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