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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DC-2 V Single Clamp, 11 mm, black angulated, for veins, 2 pcs.
S & T AG
DC-2 V BLACK
In Commercial Distribution

  • ESOT003650 ()
  • ESOT003652 ()
00365

  • Surgical A/V-shaped microvessel clamp
DC-1 Single Clamp, 8 mm, black angulated, for arteries and veins, 2 pcs.
S & T AG
DC-1 BLACK
In Commercial Distribution

  • ESOT003630 ()
  • ESOT003632 ()
00363

  • Surgical A/V-shaped microvessel clamp
Amyloid A ,Clone MC1, 6mL (Manual Use)
Slmp, LLC
(BTO) Manual Amyloid A Component (MC1) Antibody (6ml)
In Commercial Distribution

  • 00810170550225 ()
MM05-6

  • Amyloid A component IVD, antibody
Amyloid A ,Clone MC1, 10mL
Slmp, LLC
(BTO) Amyloid A Component (MC1) Antibody (10ml)
In Commercial Distribution

  • 00810170550218 ()
MM05-10

  • Amyloid A component IVD, antibody
No Description
Slmp, LLC
(BTO) Sample Amyloid A Component Antibody (2ml)
In Commercial Distribution

  • 00810170552281 ()
SAM-MM05-2

  • Amyloid A component IVD, antibody
Rabbit Monoclonal Anti-Human Serum Amyloid A (335), concentrated
Epitomics Inc.
AC-0311BULK
In Commercial Distribution

  • 00810113068220 ()


  • Serum amyloid A IVD, reagent
Rabbit Monoclonal Anti-Human Serum Amyloid A (335), 0.1 mL concentrated
Epitomics Inc.
AC-0311A
In Commercial Distribution

  • 00810113068213 ()

  • Total Volume: 0.1 Milliliter


  • Serum amyloid A IVD, reagent
Rabbit Monoclonal Anti-Human Serum Amyloid A (335), 0.5 mL concentrated
Epitomics Inc.
AC-0311B
In Commercial Distribution

  • 00810113068206 ()

  • Total Volume: 0.5 Milliliter


  • Serum amyloid A IVD, reagent
Rabbit Monoclonal Anti-Human Serum Amyloid A (335), 1 mL concentrated
Epitomics Inc.
AC-0311
In Commercial Distribution

  • 00810113068190 ()

  • Total Volume: 1 Milliliter


  • Serum amyloid A IVD, reagent
Fitzgerald Aortic Aneurysm Clamp, slightly-curved cooley jaws, 5-1/4" (13.2 cm) jaws, 13" (33.0 cm)
NOVO SURGICAL, INC.
C6675-27
In Commercial Distribution

  • 00842331124808 ()

  • Balloon Catheter Tip Length: 33 Centimeter


  • Surgical A/V-shaped microvessel clamp
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)
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages.
Wallac Oy
3093-001U
In Commercial Distribution

  • 06438147356218 ()
3093-001U

  • Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry
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)
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
Not in Commercial Distribution

  • 00404847437966 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
No Description
Roche Diagnostics GmbH
11820591160
In Commercial Distribution

  • 04015630938858 ()
11820591160

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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
INSTRUMENTATION LABORATORY COMPANY
00020005700
In Commercial Distribution

  • 08426950573395 ()
  • 18426950573392 ()
00020005700

  • Multiple coagulation factor IVD, control
HemosIL Routine Control Level 1
INSTRUMENTATION LABORATORY COMPANY
00020005600
In Commercial Distribution

  • 08426950573388 ()
  • 18426950573385 ()
00020005600

  • Multiple coagulation factor IVD, control
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 UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control
HemosIL Factor XIII Antigen
INSTRUMENTATION LABORATORY COMPANY
00020201300
In Commercial Distribution

  • 08426950358725 ()
00020201300

  • Coagulation factor XIII A subunit IVD, kit, nephelometry/turbidimetry
VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
1372101
In Commercial Distribution

  • 10758750008926 ()
  • 20758750008923 ()
1372101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HAV Total Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801823
In Commercial Distribution

  • 10758750001477 ()
  • 20758750001474 ()
6801823

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801812
In Commercial Distribution

  • 10758750001415 ()
  • 20758750001412 ()
6801812

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HAV Total Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801462
In Commercial Distribution

  • 10758750001286 ()
  • 20758750001283 ()
6801462

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026757190
In Commercial Distribution

  • 04015630939916 ()
07026757190

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026773190
In Commercial Distribution

  • 04015630939855 ()
07026773190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
5524261160
In Commercial Distribution

  • 04015630938841 ()
5524261160

  • Hepatitis A virus antigen IVD, kit, chemiluminescent immunoassay
SEEKER™ GLA Reagent (alpha-D-galactosidase)
BAEBIES, INC.
1202
In Commercial Distribution

  • 00819704020111 ()
1202

  • Newborn metabolic screen/congenital disorder IVD, reagent
No Description
THE BINDING SITE GROUP LIMITED
NK623.OPT.A
In Commercial Distribution

  • 05051700018487 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK623.S.A
In Commercial Distribution

  • 05051700017985 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
In Commercial Distribution

  • 04048474037968 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
Influenza A & B Control Slide
EMD Millipore Corporation
5010
Not in Commercial Distribution

  • 04053252789229 ()
5010

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution

  • 04053252734557 ()
3303

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution

  • 04053252729225 ()
5075

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A9 Monoclonal Antibody
EMD Millipore Corporation
3301
Not in Commercial Distribution

  • 04053252672989 ()
3301

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackie Antibody Set
EMD Millipore Corporation
3350
Not in Commercial Distribution

  • 04053252585258 ()
3350

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B2 Monoclonal Antibody
EMD Millipore Corporation
3305
Not in Commercial Distribution

  • 04053252516092 ()
3305

  • Coxsackie A/B virus antigen IVD, reagent
Influenza B Monoclonal Antibody
EMD Millipore Corporation
5018
Not in Commercial Distribution

  • 04053252473722 ()
5018

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Coxsackievirus B6 Monoclonal Antibody
EMD Millipore Corporation
3309
Not in Commercial Distribution

  • 04053252472985 ()
3309

  • Coxsackie A/B virus antigen IVD, reagent
Influenza A Monoclonal Antibody
EMD Millipore Corporation
5001
Not in Commercial Distribution

  • 04053252470226 ()
5001

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Coxsackievirus B4 Monoclonal Antibody
EMD Millipore Corporation
3307
Not in Commercial Distribution

  • 04053252408489 ()
3307

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B3 Monoclonal Antibody
EMD Millipore Corporation
3306
Not in Commercial Distribution

  • 04053252404719 ()
3306

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A Control Slides
EMD Millipore Corporation
5076
Not in Commercial Distribution

  • 04053252404290 ()
5076

  • Coxsackie A/B virus antigen IVD, reagent
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
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)
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)
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