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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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SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021710 ()
5320025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021741 ()
5351025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021734 ()
5331025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021727 ()
5330025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021703 ()
5310025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021697 ()
5300025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Tunnelling Probe Kit
Integra LifeSciences Switzerland Sàrl
IT2
In Commercial Distribution

  • M272IT21 ()
  • 10381780250340 ()
  • 10381780041207 ()
IT2

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IP2P
In Commercial Distribution

  • M272IP2P1 ()
  • 10381780250333 ()
  • 10381780041191 ()
IP2P

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IP1P
In Commercial Distribution

  • M272IP1P1 ()
  • 10381780250319 ()
  • 10381780041184 ()
IP1P

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IM3ST
In Commercial Distribution

  • M272IM3ST1 ()
  • 10381780250289 ()
  • 10381780041177 ()
IM3ST

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IM1S
In Commercial Distribution

  • M272IM1S1 ()
  • 10381780250210 ()
  • 10381780041146 ()
IM1S

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Oxygen Probe
Integra LifeSciences Switzerland Sàrl
CC1SB
In Commercial Distribution

  • M272CC1SB1 ()
  • 10381780250180 ()
  • 10381780041061 ()
CC1SB

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Combined Oxygen and Temperature Probe
Integra LifeSciences Switzerland Sàrl
CC1P1
In Commercial Distribution

  • M272CC1P11 ()
  • 10381780250173 ()
  • 10381780041078 ()
CC1P1

  • Intracerebral sensor catheter, short-term
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application.
Affinity Biologicals Inc
SAFXIII-IG-ASR-500
In Commercial Distribution

  • 10629009145016 ()


  • Assay development analyte-specific reagent IVD
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application.
Affinity Biologicals Inc
SAFXIII-IG-ASR-5
In Commercial Distribution

  • 10629009140516 ()


  • Assay development analyte-specific reagent IVD
Schiff's Reagent for Histological Staining
TRANSENE COMPANY, INC.
1
In Commercial Distribution

  • SO429852042008 ()

  • Total Volume: 1 Gallon
  • Total Volume: 1 Quart
  • Total Volume: 1 Pint
  • Total Volume: 8 Fluid Ounce
  • Total Volume: 4 Fluid Ounce
SO-429

  • Biological stain IVD
Positive and Negative Oral Fluid Controls
BRANAN MEDICAL CORPORATION
OC001
Not in Commercial Distribution

  • 00816555020222 ()
OC001

  • Multiple drugs of abuse IVD, calibrator
New Easy-to-Use Disk Format. Hardy Diagnostics now offers a convenient way of testing ß-lactamase activity in bacteria. The rapid Nitrocef test consists of a disk that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms: • Neisseria gonorrhoeae • Haemophilus spp. • Moraxella (Branhamella) catarrhalis • Staphylococcus spp. • Enterococcus spp. • Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella) The rapid Nitrocef Disk test can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. These HardyDisks™ are packages loose in a glass vial.
HARDY DIAGNOSTICS
Z7301
In Commercial Distribution

  • 00816576028887 ()
  • 00816576028894 ()
Z7301

  • Beta-lactamase production microbial reagent IVD
ACCURUN 156 Reagin (Syphilis) 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0094
In Commercial Distribution

  • 00816784020482 ()
2015-0094

  • Treponema pallidum reagin antibody IVD, control
ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0088
In Commercial Distribution

  • 00816784020444 ()
2015-0088

  • Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 141 Rubella IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0086
In Commercial Distribution

  • 00816784020420 ()
2015-0086

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
ACCURUN 136 Toxoplasma IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0083
In Commercial Distribution

  • 00816784020406 ()
2015-0083

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0081
In Commercial Distribution

  • 00816784020383 ()
2015-0081

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control
ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0072
In Commercial Distribution

  • 00816784020307 ()
2015-0072

  • Hepatitis B virus e-antigen IVD, control
ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0071
In Commercial Distribution

  • 00816784020291 ()
2015-0071

  • Hepatitis B virus e-antigen IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0041
In Commercial Distribution

  • 00816784020192 ()
2000-0041

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0040
In Commercial Distribution

  • 00816784020185 ()
2000-0040

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 31 EBV IgM 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0038
In Commercial Distribution

  • 00816784020161 ()
2000-0038

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control
ACCURUN 30 EBV IgG 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0037
In Commercial Distribution

  • 00816784020154 ()
2000-0037

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control
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