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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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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)

Light Diagnostics ™ Coxsackie Antibody Set - 04053252585258

Coxsackie Antibody Set
EMD Millipore Corporation
3350
Not in Commercial Distribution

  • 04053252585258 ()
3350

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus B2 Monoclonal Antibody - 04053252516092

Coxsackievirus B2 Monoclonal Antibody
EMD Millipore Corporation
3305
Not in Commercial Distribution

  • 04053252516092 ()
3305

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus A Control Slides - 04053252404290

Coxsackievirus A Control Slides
EMD Millipore Corporation
5076
Not in Commercial Distribution

  • 04053252404290 ()
5076

  • Coxsackie A/B virus antigen IVD, reagent

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 ™ Coxsackievirus B5 Monoclonal Antibody - 04053252332371

Coxsackievirus B5 Monoclonal Antibody
EMD Millipore Corporation
3308
Not in Commercial Distribution

  • 04053252332371 ()
3308

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus B1 Monoclonal Antibody - 04053252326264

Coxsackievirus B1 Monoclonal Antibody
EMD Millipore Corporation
3304
Not in Commercial Distribution

  • 04053252326264 ()
3304

  • Coxsackie A/B virus antigen IVD, reagent

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 ™ Coxsackievirus B Blend Monoclonal Antibodies - 04053252734557

Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution

  • 04053252734557 ()
3303

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus B Control Slides - 04053252729225

Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution

  • 04053252729225 ()
5075

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics™ Coxsackievirus A9 Monoclonal Antibody - 04053252672989

Coxsackievirus A9 Monoclonal Antibody
EMD Millipore Corporation
3301
Not in Commercial Distribution

  • 04053252672989 ()
3301

  • Coxsackie A/B virus antigen IVD, reagent

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 ™ Coxsackievirus B6 Monoclonal Antibody - 04053252472985

Coxsackievirus B6 Monoclonal Antibody
EMD Millipore Corporation
3309
Not in Commercial Distribution

  • 04053252472985 ()
3309

  • Coxsackie A/B virus antigen IVD, reagent

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

Light Diagnostics ™ Coxsackievirus B4 Monoclonal Antibody - 04053252408489

Coxsackievirus B4 Monoclonal Antibody
EMD Millipore Corporation
3307
Not in Commercial Distribution

  • 04053252408489 ()
3307

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus B3 Monoclonal Antibody - 04053252404719

Coxsackievirus B3 Monoclonal Antibody
EMD Millipore Corporation
3306
Not in Commercial Distribution

  • 04053252404719 ()
3306

  • Coxsackie A/B virus antigen IVD, reagent

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™ Coxsackievirus A24 Monoclonal Antibody - 04053252326011

Coxsackievirus A24 Monoclonal Antibody
EMD Millipore Corporation
3302
Not in Commercial Distribution

  • 04053252326011 ()
3302

  • Coxsackie A/B virus antigen IVD, reagent

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

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

D3 Fastpoint - 30014613330806

FASTPOINT FLUA/B KIT BX 2
DIAGNOSTIC HYBRIDS, INC.
01-120001.B2
In Commercial Distribution

  • 30014613330806 ()
01-120001.B2

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

D3 Fastpoint - 30014613330790

FASTPOINT FLUA/B KIT BX 1
DIAGNOSTIC HYBRIDS, INC.
01-120001.B1
In Commercial Distribution

  • 30014613330790 ()
01-120001.B1

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

D3 Fastpoint - 30014613330783

FASTPOINT FLUA/B KIT
DIAGNOSTIC HYBRIDS, INC.
01-120001
In Commercial Distribution

  • 30014613330783 ()
01-120001

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex

D3 Ultra - 30014613330479

Parainfluenza 3 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013702.V2
In Commercial Distribution

  • 30014613330479 ()
01-013702.V2

  • Human parainfluenza virus 3 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330462

Parainfluenza 2 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013602.V2
In Commercial Distribution

  • 30014613330462 ()
01-013602.V2

  • Human parainfluenza virus 2 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330455

Parainfluenza 1 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013502.V2
In Commercial Distribution

  • 30014613330455 ()
01-013502.V2

  • Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay

D3 - 30014613330448

D3 DFA 500 ML SCR REAGENT
DIAGNOSTIC HYBRIDS, INC.
01-013500.V2-BULK
In Commercial Distribution

  • 30014613330448 ()
01-013500.V2-BULK

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

D3 Ultra - 30014613330431

Adeno DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013402.V2
In Commercial Distribution

  • 30014613330431 ()
01-013402.V2

  • Adenovirus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330424

RSV DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013302.V2
In Commercial Distribution

  • 30014613330424 ()
01-013302.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330417

Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay

D3 - 30014613330400

Influenza B DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013200.V2-BULK
In Commercial Distribution

  • 30014613330400 ()
01-013200.V2-BULK

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330394

Influenza A DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013102.V2
In Commercial Distribution

  • 30014613330394 ()
01-013102.V2

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330387

Influenza A DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013100.V2-BULK
In Commercial Distribution

  • 30014613330387 ()
01-013100.V2-BULK

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330370

DFA Respiratory Virus Screening Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013010.V2
In Commercial Distribution

  • 30014613330370 ()
01-013010.V2

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

D3 Ultra - 30014613330363

DFA Respiratory Virus Screening Reagent - Bulk
DIAGNOSTIC HYBRIDS, INC.
01-013000.V2-BULK
In Commercial Distribution

  • 30014613330363 ()
01-013000.V2-BULK

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

D3 Ultra - 30014613330356

D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

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

D3 Ultra - 30014613330349

D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

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

D3 Ultra - 30014613330325

De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330318

D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330301

D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

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

D3 Ultra - 30014613330295

D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

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

D3 Ultra - 30014613330288

D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

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

Acute Hemodialysis Accessory Tray - 00886333215867

Acute Hemodialysis Accessory Tray
ARGON MEDICAL DEVICES, INC.
500331A
Not in Commercial Distribution

  • 20886333215861 ()
  • 00886333215867 ()
500331A

  • General surgical procedure kit, medicated

Hemodialysis Pack - 00886333215843

Hemodialysis Pack
ARGON MEDICAL DEVICES, INC.
500326D
Not in Commercial Distribution

  • 20886333215847 ()
  • 00886333215843 ()
500326D

  • General surgical procedure kit, medicated

Acute Hemodialysis Tray - 00886333215836

Acute Hemodialysis Tray
ARGON MEDICAL DEVICES, INC.
500320F
Not in Commercial Distribution

  • 20886333215830 ()
  • 00886333215836 ()
500320F

  • General surgical procedure kit, medicated

3M™ Attest™ - 30707387788019

3M™ Attest™ VH2O2 Tri-Metric Chemical Indicator, 250 each/pouch, 4 pouches/case, 1348E
3M COMPANY
1348E
In Commercial Distribution

  • 50707387788013 ()
  • 30707387788019 ()
  • 00707387788018 ()
1348E

  • Chemical/physical sterilization process indicator
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