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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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Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen morphology smear and 1 Pap stained and coverslipped glass sperm morphology smear, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC305
In Commercial Distribution

  • 00860010518182 ()
AQC305

  • Sperm morphology/viability control IVD
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
In Commercial Distribution

  • 00860010518175 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
Sperm Viability Quality Control. 2 stained and coverslipped sperm viability smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-viability-quality-control
Fertility Solutions, Inc.
AQC107
In Commercial Distribution

  • 00860010518168 ()
AQC107

  • Sperm morphology/viability control IVD
Sperm Morphology Quality Control - Unstained. 2 unstained, fixed, glass sperm morphology smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC205
In Commercial Distribution

  • 00860010518151 ()
AQC205

  • Sperm morphology/viability control IVD
Sperm Morphology Quality Control - Stained 2 Pap stained and coverslipped glass sperm morphology smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC105
In Commercial Distribution

  • 00860010518144 ()
AQC105

  • Sperm morphology/viability control IVD
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
Not in Commercial Distribution

  • 08600105181752 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable
96 well ELISA for the detection of anti-TPO antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA04
Not in Commercial Distribution

  • 00816879020045 ()


  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)
VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
UTAK-WBC VOL 1 SD
In Commercial Distribution

  • B800UTAKWBCVOL1SD5 ()
  • B800UTAKWBCVOL1SD0 ()

  • Total Volume: 10 Milliliter
UTAK-WBC VOL 1 SD

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES PLUS LOW
UTAK LABORATORIES, INC.
VOL+ L MCV
In Commercial Distribution

  • B800VOLLMCV0 ()

  • Total Volume: 5 Milliliter
VOL+ L MCV

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES PLUS LOW
UTAK LABORATORIES, INC.
VOL+ H MCV
In Commercial Distribution

  • B800VOLHMCV5 ()
  • B800VOLHMCV0 ()

  • Total Volume: 5 Milliliter
VOL+ H MCV

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Germ Tube Cryo™, for Candida albicans, 0.5ml, ready to use, 20 vials per package A ready-to-use germ tube solution made up of stabilized animal serum, comes pre-measured in vials. No mixing, measuring, or aliquoting is required! Eliminates exposure to human serum. 0.5ml in each vial. Germ tubes develop on C. albicans within one hour. Serum formula is enhanced for more rapid and luxuriant production of germ tubes.
HARDY DIAGNOSTICS
Z217
In Commercial Distribution

  • 00819398026598 ()
  • 00819398026604 ()
Z217

  • Candida albicans microbial identification reagent IVD
Coagulase Cryo™, frozen rabbit plasma for tube or slide coagulase test for Staphylococcus aureus detection, 0.5ml fill, 2ml vial, 20 per package The ready-to-use Coagulase Cryo is used to differentiate Staphylococcus species based on the ability to produce coagulase. It contains rabbit plasma, and is used to test for the production of free coagulase. The tube coagulase test is used to identify pathogenic staphylococci. The Staphylococcus species that are capable of producing coagulase include S. aureus (potentially pathogenic in humans and animals) and the animal isolates S. intermedius and S. hyicus.
HARDY DIAGNOSTICS
Z202
In Commercial Distribution

  • 00819398026574 ()
  • 00819398026581 ()
Z202

  • Coagulase production microbial reagent IVD
No Description
Bion Enterprises, Ltd.
QHS-3504
In Commercial Distribution

  • B110QHS35040 ()
QHS-3504

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test Control Slide Pack
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H399UL
Not in Commercial Distribution

  • 05391516746144 ()

  • 10 Slides
8H399UL

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
Bartels® Herpes Simplex Virus Antigen Control Slides
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-47B
Not in Commercial Distribution

  • 05391516745949 ()
  • 05391516748674 ()

  • 10 Slides
B1029-47B

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
Bartels® Anti-HSV mouse monoclonal FITC conjugate
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-47C
Not in Commercial Distribution

  • 05391516745925 ()

  • 50-100 Tests
B1029-47C

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagent
Bartels® HSV Type 1 and Type 2 Antigen Control Slides
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-44C
Not in Commercial Distribution

  • 05391516745864 ()

  • 5 Sets
B1029-44C

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
Polyclonal Rabbit Anti- Herpes Simplex Virus Type 1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
B0114
In Commercial Distribution

  • 05700572001614 ()

  • Total Volume: 2 Milliliter


  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, antibody
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